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

Condition(s) targeted: Hypertension

Intervention: Valsartan + amlodipine (Drug); Valsartan + HCTZ (Drug); Amlodipine + HCTZ (Drug); Valsartan + amlodipine + HCTZ (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Principal Investigator, Affiliation: Novartis

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.

Official title: An 8-Week, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Valsartan/HCTZ/Amlodipine Compared to Valsartan/HCTZ, Valsartan/Amlodipine, and HCTZ/Amlodipine in Patients With Moderate to Severe Hypertension.

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Change from baseline diastolic blood pressure after 8 weeks

Change from baseline systolic blood pressure after 8 weeks

Secondary outcome:

Blood pressure less than 140/90 mmHg after 8 weeks

Systolic blood pressure less than 140 mmHg or diastolic blood pressure less than 90 mmHg after 8 weeks

Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease after 8 weeks or systolic blood pressure less than 140 mmHg or at least a 15 mmHg decrease after 8 weeks

Ambulatory blood pressure and standing systolic and diastolic blood pressure measurements

Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 8 weeks

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of moderate to severe hypertension (MSDBP ≥ 100 mmHg and < 120 mmHg, MSSBP ≥

145 mmHg and < 200 mmHg).

Exclusion Criteria:

- 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.

Novartis Pharmaceuticals Corporation, E. Hanover, New Jersey 07936, United States

Starting date: May 2006
Last updated: October 24, 2007