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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypertension

In brief

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

Key facts

Study ID

NCT00765674

Run by

Novartis

People needed

1191

Starts

2008-09-01

Expected to finish

2009-08-01

Last updated by the study team

2011-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• 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)

Full record on ClinicalTrials.gov

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