Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension
This study has been completed.
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00765674
First received: October 2, 2008
Last updated: April 15, 2011
Last verified: April 2011
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Purpose
This study evaluated the efficacy (blood pressure lowering effect) and safety of aliskiren/amlodipine/hydrochlorothiazide in patients with moderate to severe hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Aliskiren Drug: Amlodipine Drug: Hydrochlorothiazide (HCTZ) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) [ Time Frame: Baseline to end of study (Week 8) ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) [ Time Frame: Baseline to end of study (Week 8) ] [ Designated as safety issue: No ]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.
- Percentage of Patients Achieving Blood Pressure Control at the End of the Study (Week 8) [ Time Frame: End of study (Week 8) ] [ Designated as safety issue: No ]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.
- Change in Mean 24-hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study (Week 8) [ Time Frame: Baseline to end of study (Week 8) ] [ Designated as safety issue: No ]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.
| Enrollment: | 1191 |
| Study Start Date: | September 2008 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: Aliskiren
150 and 300 mg tablets
Drug: Amlodipine
5 and 10 mg capsules
Drug: Placebo
tablet
Drug: Placebo
capsules
|
|
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.
|
Drug: Aliskiren
150 and 300 mg tablets
Drug: Hydrochlorothiazide (HCTZ)
12.5 and 25 mg capsules
Drug: Placebo
tablet
Drug: Placebo
capsules
|
|
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.
|
Drug: Amlodipine
5 and 10 mg capsules
Drug: Hydrochlorothiazide (HCTZ)
12.5 and 25 mg capsules
Drug: Placebo
tablet
|
|
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.
|
Drug: Aliskiren
150 and 300 mg tablets
Drug: Amlodipine
5 and 10 mg capsules
Drug: Hydrochlorothiazide (HCTZ)
12.5 and 25 mg capsules
Drug: Placebo
tablet
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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).
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765674
Locations
| United States, Colorado | |
| Investigative Site | |
| Denver, Colorado, United States | |
| Australia | |
| Investigative Site | |
| Sydney, Australia | |
| Canada | |
| Investigative Site | |
| Ottawa, Canada | |
| Denmark | |
| Investigative Site | |
| Copenhagen, Denmark | |
| Germany | |
| Investigative Site | |
| Berlin, Germany | |
| Israel | |
| Investigative Site | |
| Jerusalem, Israel | |
| Italy | |
| Investigative Site | |
| Rome, Italy | |
| Latvia | |
| Investigative Site | |
| Riga, Latvia | |
| Lithuania | |
| Investigative Site | |
| Vilnius, Lithuania | |
| Romania | |
| Investigative Site | |
| Bucharest, Romania | |
| Sweden | |
| Investigative Site | |
| Stockholm, Sweden | |
| Turkey | |
| Investigative Site | |
| Ankara, Turkey | |
Sponsors and Collaborators
Novartis
More Information
No publications provided
| Responsible Party: | External Affairs, Novartis |
| ClinicalTrials.gov Identifier: | NCT00765674 History of Changes |
| Other Study ID Numbers: | CSAH100A2302 |
| Study First Received: | October 2, 2008 |
| Results First Received: | January 12, 2011 |
| Last Updated: | April 15, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices Canada: Health Canada Italy: National Institute of Health Sweden: Medical Products Agency Romania: National Medicines Agency Australia: Department of Health and Ageing Therapeutic Goods Administration United States: Food and Drug Administration Denmark: Danish Medicines Agency Israel: Ministry of Health Lithuania: State Medicine Control Agency - Ministry of Health Zanzibar: Ministry of Health and Social Welfare Latvia: State Agency of Medicines |
Keywords provided by Novartis:
|
aliskiren antihypertensive hypertension renin inhibitor moderate-severe hypertension |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Amlodipine Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions |
Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Calcium Channel Blockers Vasodilator Agents |
ClinicalTrials.gov processed this record on May 19, 2013