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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00239538
Registration number
NCT00239538
Ethics application status
Date submitted
14/10/2005
Date registered
17/10/2005
Date last updated
8/11/2013
Titles & IDs
Public title
SMOOTH - Blood Pressure Control in Diabetic/Obese Patients
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Scientific title
Prospective, Randomized, Open-label, Blinded Endpoint, Forced Titration Study to Compare Telmisartan Combined With HCTZ (80mg/12.5mg), to Valsartan Combined With HCTZ (160mg/12.5mg), for the Control of Mild-to-moderate Hypertension in Obese Patients With Type 2 Diabetes Mellitus Using ABPM.
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Secondary ID [1]
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502.399
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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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Diabetes Mellitus, Type 2
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Condition category
Condition code
Cardiovascular
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Hypertension
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Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - telmisartan combined with hydrochlorothiazide (80/12.5 mg)
Treatment: Drugs - valsartan combined with hydrochlorothiazide (160/12.5mg)
Treatment: Drugs: telmisartan combined with hydrochlorothiazide (80/12.5 mg)
Treatment: Drugs: valsartan combined with hydrochlorothiazide (160/12.5mg)
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Intervention code [1]
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Treatment: Drugs
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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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Changes from baseline in the mean SBP and DBP as measured by ambulatory blood pressure monitoring (ABPM)
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Assessment method [1]
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Timepoint [1]
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10 weeks
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Secondary outcome [1]
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Changes from baseline in the last 6-hour ABPM mean (relative to dose time) pulse pressure.
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Assessment method [1]
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Timepoint [1]
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10 weeks
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Secondary outcome [2]
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Changes from baseline in the 24-hour ABPM mean (relative to dose time) for SBP, DBP and pulse pressure.
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Assessment method [2]
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Timepoint [2]
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10 weeks
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Secondary outcome [3]
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Changes from baseline in the ABPM mean (relative to clock time) for SBP, DBP, and pulse pressure during the morning, daytime and night time periods of the 24-hour dosing interval.
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Assessment method [3]
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Timepoint [3]
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10 weeks
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Secondary outcome [4]
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Changes from baseline in SBP and DBP load during the 24-hour dosing interval.
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Assessment method [4]
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Timepoint [4]
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10 weeks
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Secondary outcome [5]
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Responder rates based on the 24-hour ABPM mean (relative to dose time) blood pressures defined
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Assessment method [5]
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Timepoint [5]
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10 weeks
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Secondary outcome [6]
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In-clinic trough cuff blood pressure measures at the end of both a 4-week (Visit 4) treatment period and a 10-week (Visit 6) treatment period.
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Assessment method [6]
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Timepoint [6]
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4 weeks and 10 weeks
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Secondary outcome [7]
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Responder rates based on the mean seated trough cuff measurements
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Assessment method [7]
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Timepoint [7]
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4 weeks and 10 weeks
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Secondary outcome [8]
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Metabolic and inflammatory marker changes from baseline
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Assessment method [8]
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Timepoint [8]
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up to 10 weeks
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Eligibility
Key inclusion criteria
1. Ability to provide written informed consent.
2. Hypertension defined as a mean seated DBP of 95-109 (inclusive) mmHg, and/or SBP of
140-179 (inclusive) mmHg, measured by BpTRU electronic or manual cuff at Visit 2.
3. 24-hour mean DBP of >= 85 mmHg, and/or SBP = 130 mmHg, measured by ABPM at Visit 3.
4. 30 years of age or greater.
5. Ability to stop current antihypertensive therapy and other disallowed medications
without risk to the patient.
6. Diagnosis of type-2 diabetes mellitus with HbA1C less than or equal to 10%.
7. Overweight or obese as defined by a BMI >= 27 kg/m2 in non-Asians and >= 24 kg/m2 in
Asians.
8. Negative UPT for females.
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Minimum age
30
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
1. Pre-menopausal women, not surgically sterile or, not nursing/pregnant or are of
child-bearing potential and will not practice acceptable methods of birth control
during study.
2. Night shift workers
3. Mean sitting SBP >= 180 mmHg or mean sitting DBP >= 110 mmHg during any visit of the
placebo run-in period.
4. Known or suspected secondary hypertension. Hepatic and/or renal dysfunction
5. Fasting serum glucose > 17 mmol/l (or 300 mg/dl) at visit 2
6. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients
on dialysis or post-renal transplant patients.
7. Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
8. Uncorrected volume depletion.
9. Primary aldosteronism.
10. Hereditary fructose intolerance.
11. Biliary obstructive disorders (e.g., cholestasis).
12. Congestive heart failure
13. Stroke within the past six months.
14. Documented severe obstructive coronary artery disease.
15. Myocardial infarction, cardiac surgery or unstable angina within the past three
months.
16. PCI (percutaneous coronary intervention) within the past three months or planned
during trial period.
17. Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other
clinically relevant cardiac arrhythmias.
18. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant
stenosis of the aortic or mitral valve.
19. Patients with type-1 diabetes mellitus.
20. Patients who have previously experienced symptoms of angioedema during ACE or ARB
treatment.
21. History of drug or alcohol dependency in past six months.
22. Chronic administration of any medications known to affect blood pressure, except
medication allowed by the protocol.
23. Any investigational drug therapy within the past month.
24. Known hypersensitivity to any component of the study drug.
25. Concurrent use of corticosteroids, colestipol or cholestyramine resins.
26. Any clinical condition which would not allow safe completion of the protocol.
27. Inability to comply with the protocol.
28. Any surgery that is, at the time of screening, planned to take place during the study
period.
29. History of non-compliance with prescribed medications.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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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
1/01/2003
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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
840
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Boehringer Ingelheim Investigational Site - Kippa-Ring
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Recruitment hospital [2]
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Emeritus Research - Malvern
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Recruitment hospital [3]
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Boehringer Ingelheim Investigational Site - Prahran
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Recruitment postcode(s) [1]
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4021 - Kippa-Ring
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Recruitment postcode(s) [2]
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3144 - Malvern
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Recruitment postcode(s) [3]
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3181 - Prahran
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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Arizona
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Country [3]
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United States of America
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State/province [3]
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California
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Country [4]
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United States of America
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State/province [4]
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District of Columbia
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Country [5]
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United States of America
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Florida
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Country [6]
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United States of America
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State/province [6]
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Illinois
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Country [7]
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United States of America
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State/province [7]
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Indiana
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Country [8]
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United States of America
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Kansas
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Country [9]
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United States of America
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State/province [9]
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Louisiana
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United States of America
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State/province [10]
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Maryland
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State/province [11]
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Missouri
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Montana
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United States of America
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State/province [13]
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New York
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Country [14]
0
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United States of America
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State/province [14]
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North Carolina
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Country [15]
0
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United States of America
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Ohio
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United States of America
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Oklahoma
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Tennessee
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Texas
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Wisconsin
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Argentina
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Argentina
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Coronel Suárez
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Argentina
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Rosario, Sta. Fe
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Alberta
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Newfoundland and Labrador
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Saskatchewan
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Korea, Republic of
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Busan
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Daegu
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Seoul
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Mexico
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Col. Del Valle
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Mexico
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Col. Magdalena de las Salinas
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Mexico
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Col. Sección 16, México, D.F.
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Mexico
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Guadalajara, Jalisco
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Mexico
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Zapopan, Jalisco
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Auckland
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New Zealand
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Christchurch
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Taiwan
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State/province [45]
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Taipei
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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 study is to demonstrate that telmisartan 80 mg combined with
hydrochlorothiazide 12.5 mg (T80/H12.5) is at least as effective and possibly superior to
valsartan 160 mg combined with hydrochlorothiazide 12.5 mg (V160/H12.5) in lowering mean
ambulatory systolic blood pressure (SBP) and diastolic blood pressure (DBP) during the last 6
hours of the 24-hour dosing interval at the end of a 10-week treatment period in
mild-to-moderate hypertensive, overweight or obese patients with type 2 diabetes mellitus
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00239538
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Boehringer Ingelheim Study Coordinator
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Address
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B.I. Canada Ltd.
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00239538
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