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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/NCT00765674
Registration number
NCT00765674
Ethics application status
Date submitted
2/10/2008
Date registered
3/10/2008
Date last updated
9/05/2011
Titles & IDs
Public title
Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension
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Scientific title
An 8 Week, Double-blind, Randomized, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate to Severe Hypertension
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Secondary ID [1]
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CSAH100A2302
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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
Treatment: Drugs - Aliskiren
Treatment: Drugs - Amlodipine
Treatment: Drugs - Hydrochlorothiazide (HCTZ)
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Experimental: Aliskiren / amlodipine - Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
Experimental: Aliskiren / hydrochlorothiazide - Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
Experimental: Amlodipine / hydrochlorothiazide - Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
Experimental: Aliskiren / amlodipine / hydrochlorothiazide - Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
Treatment: Drugs: Aliskiren
150 and 300 mg tablets
Treatment: Drugs: Amlodipine
5 and 10 mg capsules
Treatment: Drugs: Hydrochlorothiazide (HCTZ)
12.5 and 25 mg capsules
Treatment: Drugs: Placebo
tablet
Treatment: Drugs: Placebo
capsules
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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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Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)
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Assessment method [1]
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Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.
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Timepoint [1]
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Baseline to end of study (Week 8)
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Secondary outcome [1]
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Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
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Assessment method [1]
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Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.
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Timepoint [1]
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Baseline to end of study (Week 8)
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Secondary outcome [2]
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Percentage of Patients Achieving Blood Pressure Control at the End of the Study (Week 8)
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Assessment method [2]
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Blood pressure control was defined as a msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated.
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Timepoint [2]
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End of study (Week 8)
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Secondary outcome [3]
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Change in Mean 24-hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study (Week 8)
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Assessment method [3]
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Twenty-four hour ambulatory blood pressure monitoring (ABPM) was performed in a subset of patients twice during the study, once at baseline and again at Week 8. The ABPM device was placed on the non-dominant arm between 7:00 and 10:00 am and verification readings obtained. If they were successful, the investigator initiated the 24 hour reading and instructed the patient regarding ABPM procedures. On the next day, the ABPM device was removed if it had been worn for a minimum of 24 hours. The ABPM data were downloaded and evaluated on site.
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Timepoint [3]
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Baseline to end of study (Week 8)
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Eligibility
Key inclusion criteria
- Male or female
- 18 years of age or older
- msDBP and msSBP requirements:
- 3A:
- Diagnosis of moderate to severe hypertension (msSBP = 160 mmHg and < 200
mmHg, and/or msDBP = 100 mmHg and < 120 mmHg) at Visits 4, 5 or 6
(Qualifying BP visit)
- In addition, at the visit immediately prior to the above qualifying visit,
patients were also to have msSBP = 145 mmHg and < 200 mmHg and msDBP = 95
mmHg and < 120 mmHg) at Visits 3, 5 or 5.
- Patients had to meet the above two sets of requirements at subsequent
adjacent visits, i.e. either Visits 3 and 4, Visits 4 and 5, or Visits 5 and
6.
- OR
- 3B:
- msSBP = 180 mmHg and < 200 mmHg with msDBP = 95 mmHg and < 120 mmHg, or
msDBP = 110 mmHg and < 120 mmHg with msSBP = 150 mmHg and < 200 mmHg after
at least one week of treatment with placebo (Visit 3 and on).
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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
- Continued use of anti-hypertensive medicines or use of 4 or more hypertensive
medicines at study start
- Patients with an msSBP = 200 mmHg or msDBP = 120 mmHg at any time during the placebo
run-in period were to be discontinued from the study.
- Extremely elevated (defined) blood pressure at any point during the study
- Pregnant or lactating women
- Pre-menopausal women not taking accepted form of birth control
- History or evidence of secondary form of hypertension
- History of cardiovascular conditions
Other protocol-defined inclusion/exclusion criteria applied to the study.
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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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
1/09/2008
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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
1/08/2009
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Sample size
Target
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Accrual to date
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Final
1191
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Investigative Site - Sydney
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Recruitment postcode(s) [1]
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- Sydney
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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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Colorado
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Canada
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State/province [2]
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Ottawa
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Denmark
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State/province [3]
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Copenhagen
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Country [4]
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Germany
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State/province [4]
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Berlin
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Country [5]
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Israel
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State/province [5]
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Jerusalem
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Country [6]
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Italy
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State/province [6]
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Rome
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Country [7]
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Latvia
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State/province [7]
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Riga
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Country [8]
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Lithuania
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State/province [8]
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Vilnius
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Country [9]
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Romania
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State/province [9]
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Bucharest
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Country [10]
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Sweden
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State/province [10]
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Stockholm
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Country [11]
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Turkey
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State/province [11]
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Ankara
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis
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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
This study evaluated the efficacy (blood pressure lowering effect) and safety of
aliskiren/amlodipine/hydrochlorothiazide in patients with moderate to severe hypertension.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00765674
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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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Address
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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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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00765674
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