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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
CSAH100A2302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)
Timepoint [1] 0 0
Baseline to end of study (Week 8)
Secondary outcome [1] 0 0
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
Timepoint [1] 0 0
Baseline to end of study (Week 8)
Secondary outcome [2] 0 0
Percentage of Patients Achieving Blood Pressure Control at the End of the Study (Week 8)
Timepoint [2] 0 0
End of study (Week 8)
Secondary outcome [3] 0 0
Change in Mean 24-hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study (Week 8)
Timepoint [3] 0 0
Baseline to end of study (Week 8)

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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2009
Sample size
Target
Accrual to date
Final
1191
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigative Site - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
Canada
State/province [2] 0 0
Ottawa
Country [3] 0 0
Denmark
State/province [3] 0 0
Copenhagen
Country [4] 0 0
Germany
State/province [4] 0 0
Berlin
Country [5] 0 0
Israel
State/province [5] 0 0
Jerusalem
Country [6] 0 0
Italy
State/province [6] 0 0
Rome
Country [7] 0 0
Latvia
State/province [7] 0 0
Riga
Country [8] 0 0
Lithuania
State/province [8] 0 0
Vilnius
Country [9] 0 0
Romania
State/province [9] 0 0
Bucharest
Country [10] 0 0
Sweden
State/province [10] 0 0
Stockholm
Country [11] 0 0
Turkey
State/province [11] 0 0
Ankara

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00765674
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00765674