Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension
NCT ID: NCT00765674
Last Updated: 2011-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1191 participants
INTERVENTIONAL
2008-09-30
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Amlodipine
5 and 10 mg capsules
Hydrochlorothiazide (HCTZ)
12.5 and 25 mg capsules
Placebo
tablet
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.
Aliskiren
150 and 300 mg tablets
Amlodipine
5 and 10 mg capsules
Hydrochlorothiazide (HCTZ)
12.5 and 25 mg capsules
Placebo
tablet
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.
Aliskiren
150 and 300 mg tablets
Amlodipine
5 and 10 mg capsules
Placebo
tablet
Placebo
capsules
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.
Aliskiren
150 and 300 mg tablets
Hydrochlorothiazide (HCTZ)
12.5 and 25 mg capsules
Placebo
tablet
Placebo
capsules
Interventions
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Aliskiren
150 and 300 mg tablets
Amlodipine
5 and 10 mg capsules
Hydrochlorothiazide (HCTZ)
12.5 and 25 mg capsules
Placebo
tablet
Placebo
capsules
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis
Locations
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Investigative Site
Denver, Colorado, United States
Investigative Site
Sydney, , Australia
Investigative Site
Ottawa, , Canada
Investigative Site
Copenhagen, , Denmark
Investigative Site
Berlin, , Germany
Investigative Site
Jerusalem, , Israel
Investigative Site
Rome, , Italy
Investigative Site
Riga, , Latvia
Investigative Site
Vilnius, , Lithuania
Investigative Site
Bucharest, , Romania
Investigative Site
Stockholm, , Sweden
Investigative Site
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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CSAH100A2302
Identifier Type: -
Identifier Source: org_study_id
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