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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00624052
Registration number
NCT00624052
Ethics application status
Date submitted
5/02/2008
Date registered
26/02/2008
Date last updated
20/05/2014
Titles & IDs
Public title
26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension
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Scientific title
An Open Label Trial of the Efficacy and Safety of Chronic Administration of the Fixed Dose Combination of Telmisartan 40mg + Amlodipine 10mg or Fixed Dose Combination of Telmisartan 80mg + Amlodipine 10mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension
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Secondary ID [1]
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1235.8
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypertension
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Condition category
Condition code
Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Trough Seated Diastolic Blood Pressure (DBP) Control
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Assessment method [1]
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The number of patients who reached the target DBP of \<90mmHg
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Timepoint [1]
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End of study (34 weeks or last value on treatment)
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Secondary outcome [1]
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Trough Seated Systolic Blood Pressure (SBP) Control
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Assessment method [1]
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The number of patients who reached the target SBP of \>=140mmHg
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Timepoint [1]
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End of study (34 weeks or last value on treatment)
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Secondary outcome [2]
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Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure
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Assessment method [2]
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Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.6
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Timepoint [2]
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Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment
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Secondary outcome [3]
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Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052
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Assessment method [3]
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The difference between the last available troughs represents the additional reduction in DBP in this study
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Timepoint [3]
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Last available trough in NCT00553267 to end of study (34 weeks or last value on treatment)
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Secondary outcome [4]
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Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure
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Assessment method [4]
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Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.6
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Timepoint [4]
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Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment
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Secondary outcome [5]
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Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052
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Assessment method [5]
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The difference between the last available troughs represents the additional reduction in SBP in this study
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Timepoint [5]
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Last available trough in NCT00624052 to end of study (34 weeks or last value on treatment)
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Secondary outcome [6]
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Trough Seated DBP Response
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Assessment method [6]
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The number of patients who reach the target DBP of \<90mmHg or had a reduction in DBP \>= 10mmHg
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Timepoint [6]
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End of study (34 weeks or last value on treatment)
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Secondary outcome [7]
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Trough Seated SBP Response
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Assessment method [7]
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The number of patients who reach the target SBP of \<140mmHg or had a reduction in SBP \>= 15 mmHg
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Timepoint [7]
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End of study (34 weeks or last value on treatment)
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Secondary outcome [8]
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Trough BP Normality Classes
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Assessment method [8]
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The number of patients who reach predefined BP categories
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Timepoint [8]
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End of study (34 weeks or last value on treatment)
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Secondary outcome [9]
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Time to First Additional Antihypertensive
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Assessment method [9]
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Time from first intake of medication to first intake of an antihypertensive other than the study drug
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Timepoint [9]
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up to 34 weeks
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Secondary outcome [10]
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Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control
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Assessment method [10]
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The number of patients with DBP control (DBP\>=90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment
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Timepoint [10]
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up to 34 weeks
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Secondary outcome [11]
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Additional Reduction in DBP by Use of Additional Antihypertensive Therapy
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Assessment method [11]
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Difference in trough DBP from last visit before add-on therapy and last visit during NCT00624052
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Timepoint [11]
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up to 34 weeks
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Secondary outcome [12]
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Additional Reduction in SBP by Use of Additional Antihypertensive Therapy
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Assessment method [12]
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Difference in trough SBP from last visit before add-on therapy and last visit during NCT00624052
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Timepoint [12]
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up to 34 weeks
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Secondary outcome [13]
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Trough DBP Control Pre- and Post- Uptitration
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Assessment method [13]
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The number of patients with DBP control (DBP\<90 mmHg). Last trough DBP measurement before uptitration to telmisartan 80mg and amlodipine 10mg compared to first trough DBP taken after uptitration. Uptitration could be based DBP\>90 or investigator opinion.
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Timepoint [13]
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up to 34 weeks
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Eligibility
Key inclusion criteria
- diagnosis of essential hypertension
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
* development of any condition in the preceding trial that could be worsened by telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10).
* discontinuation from the preceding trial.
* known or suspected secondary hypertension.
* mean seated systolic blood pressure (SBP) >= 180 mmHg and/or mean seated diastolic blood pressure (DBP) >= 120 mmHg at any visit.
* any clinically significant hepatic impairment or severe renal impairment bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal transplant.
* clinically relevant hyperkalaemia.
* uncorrected volume or sodium depletion.
* primary aldosteronism.
* hereditary fructose or lactose intolerance.
* symptomatic congestive heart failure.
* patients who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs).
* any new drug or alcohol dependency since signing consent of the preceding trial.
* concurrent participation in another clinical trial or any investigational therapy since completing the preceding trial.
* hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.
* known allergic hypersensitivity to any component of the formulations under investigation. [Includes known hypersensitivity to telmisartan or other ARBs or amlodipine or other dihydropyridine calcium channel blockers (CCBs).] non-compliance with study medication (defined as <80% or >120%) during the preceding trial.
* administration of ARBs or dihydropyridine CCBs (apart from trial medication). any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
838
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
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Recruitment hospital [1]
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1235.8.61003 Boehringer Ingelheim Investigational Site - Gosford
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Recruitment hospital [2]
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1235.8.61004 Boehringer Ingelheim Investigational Site - Liverpool
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Recruitment hospital [3]
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1235.8.61002 Boehringer Ingelheim Investigational Site - Kippa-Ring
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Recruitment hospital [4]
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1235.8.61001 Boehringer Ingelheim Investigational Site - Milton
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Recruitment hospital [5]
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1235.8.61005 Boehringer Ingelheim Investigational Site - Elizabeth Vale
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Recruitment postcode(s) [1]
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- Gosford
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Recruitment postcode(s) [2]
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- Liverpool
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Recruitment postcode(s) [3]
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- Kippa-Ring
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Recruitment postcode(s) [4]
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- Milton
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Recruitment postcode(s) [5]
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- Elizabeth Vale
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Eggenburg
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Austria
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Hainburg a.d. Donau
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Austria
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Wien
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Bulgaria
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Bourgas
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Bulgaria
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Sofia
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Czech Republic
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Benatky nad Jizerou
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Czech Republic
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Brno
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Czech Republic
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Plzen
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Czech Republic
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Praha 5
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Czech Republic
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Pribram
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Czech Republic
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Slany
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Czech Republic
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Strakonice
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Ireland
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Birr
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Ireland
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Carrigtowhill
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Ireland
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Gorey, Co. Wexford
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Ireland
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Mallow
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Ireland
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New Ross
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Italy
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Italy
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Italy
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Ferrara
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New Zealand
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Dunedin
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New Zealand
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Otahuhu, Auckland
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New Zealand
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Tauranga
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Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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Slovakia
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Dolny Kubin
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Slovakia
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Kralovsky Chmlec
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Slovakia
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Liptovsky Mikulas
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Slovakia
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Povazska Bystrica
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Slovakia
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Presov
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Slovakia
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Trencin
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Slovakia
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Vrable
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Jerez de la Frontera (Cádiz)
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Spain
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L'Hospitalet de Llobregat (Barcelona)
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Spain
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Madrid
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Spain
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Mataró
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Spain
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Oviedo
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Spain
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Santa Coloma de Gramanet
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Ukraine
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Dnepropetrovsk
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Ukraine
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Kharkov
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Ukraine
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Kiev
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Ukraine
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Lvov
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Ukraine
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Odessa
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Ukraine
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Zaporozhye
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United Kingdom
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Bexhill on Sea
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United Kingdom
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Blackpool
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United Kingdom
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Burbage
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United Kingdom
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Chestfield, Whitstable
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United Kingdom
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Chorley
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United Kingdom
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Edgbaston, Birmingham
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United Kingdom
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Ely
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United Kingdom
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Fowey
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United Kingdom
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Glasgow
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United Kingdom
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Penzance
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United Kingdom
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Plymouth
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United Kingdom
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Reading
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United Kingdom
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St. Austell
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United Kingdom
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Whitstable
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Boehringer Ingelheim
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10) during open-label treatment for at least six months. An additional objective is to assess the efficacy and safety of concomitant administration of either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of hypertension. The primary endpoint is the proportion of patients achieving DBP control (defined as mean seated DBP \< 90 mmHg at trough i.e. approximately 24 hours after last dose of study treatment) at six months of treatment or at last trough observation during the treatment period (i.e. last trough observation carried forward).
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Trial website
https://clinicaltrials.gov/study/NCT00624052
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Trial related presentations / publications
Neldam S, Edwards C, Lang M, Jones R; TEAMSTA-5 and TEAMSTA-10 Investigators. Long-Term Tolerability and Efficacy of Single-Pill Combinations of Telmisartan 40-80 mg Plus Amlodipine 5 or 10 mg in Patients Whose Blood Pressure Was Not Initially Controlled by Amlodipine 5-10 mg: Open-Label, Long-Term Follow-Ups of the TEAMSTA-5 and TEAMSTA-10 Studies. Curr Ther Res Clin Exp. 2012 Feb;73(1-2):65-84. doi: 10.1016/j.curtheres.2012.02.004.
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Public notes
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Contacts
Principal investigator
Name
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Boehringer Ingelheim
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Address
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Boehringer Ingelheim
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Phone
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Email
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Contact person for public queries
Name
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Address
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00624052
Download to PDF