8-week Study to Evaluate Safety and Efficacy of Various Combinations of Valsartan, HCTZ, and Amlodipine in Patients With Moderate to Severe Hypertension

Completed · Phase 3

Conditions studied: Hypertension

In brief

The purpose of this study is to determine the safety and efficacy of the various combinations of valsartan, HCTZ, and amlodipine in patients with moderate to severe hypertension.

Key facts

Study ID

NCT00327587

Run by

Novartis

People needed

2279

Starts

2006-05-01

Expected to finish

2007-08-01

Last updated by the study team

2011-11-08

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Diagnosis of moderate to severe hypertension (MSDBP ≥ 100 mmHg and < 120 mmHg, MSSBP ≥ 145 mmHg and < 200 mmHg).

You may not qualify if…

• Patients on two or more antihypertensive drugs with MSSBP ≥ 180 mmHg and/or MSDBP ≥ 110 mmHg at Visit 1.
• Patients on three or more antihypertensive drugs with MSDBP ≥ 90 mmHg and < 110 mmHg, and/or MSSBP ≥ 140 mmHg and < 180 mmHg at Visit 1.
• Patients on four or more antihypertensive drugs at Visit 1.
• Arm circumference > 42 cm for patients participating in ABPM.
• Other protocol-defined exclusion criteria may apply.

Where it is running

• Novartis Pharmaceuticals Corporation — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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