Clinical trial NCT00765674: Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: aliskiren
antihypertensive
hypertension
renin inhibitor
moderate-severe hypertension
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-10-03
Enrollment: 1191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluated the efficacy (blood pressure lowering effect) and safety of aliskiren/amlodipine/hydrochlorothiazide in patients with moderate to severe hypertension.


Eligibility 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.

Primary outcomes:
measure: Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)
timeFrame: Baseline to end of study (Week 8)
Secondary outcomes:
measure: Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
timeFrame: Baseline to end of study (Week 8)
measure: Percentage of Patients Achieving Blood Pressure Control at the End of the Study (Week 8)
timeFrame: End of study (Week 8)
measure: Change in Mean 24-hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study (Week 8)
timeFrame: Baseline to end of study (Week 8)
Other outcomes:
Locations:
city: Denver
country: United States
facility: Investigative Site
state: Colorado
city: Sydney
country: Australia
facility: Investigative Site
city: Ottawa
country: Canada
facility: Investigative Site
city: Copenhagen
country: Denmark
facility: Investigative Site
city: Berlin
country: Germany
facility: Investigative Site
city: Jerusalem
country: Israel
facility: Investigative Site
city: Rome
country: Italy
facility: Investigative Site
city: Riga
country: Latvia
facility: Investigative Site
city: Vilnius
country: Lithuania
facility: Investigative Site
city: Bucharest
country: Romania
facility: Investigative Site
city: Stockholm
country: Sweden
facility: Investigative Site
city: Ankara
country: Turkey
facility: Investigative Site
Study officials:
References: