Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension

Condition(s) targeted: Hypertension

Intervention: Aliskiren (Drug); Amlodipine (Drug); Hydrochlorothiazide (HCTZ) (Drug); Placebo (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

This study evaluated the efficacy (blood pressure lowering effect) and safety of aliskiren/amlodipine/hydrochlorothiazide in patients with moderate to 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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)

Secondary outcome:

Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)

Percentage of Patients Achieving Blood Pressure Control at the End of the Study (Week 8)

Change in Mean 24-hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study (Week 8)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

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

Investigative Site, Denver, Colorado, United States

Starting date: September 2008
Last updated: April 15, 2011