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.”

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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Valsartan + amlodipine
• Drug: Valsartan + HCTZ
• Drug: Amlodipine + HCTZ
• Drug: Valsartan + amlodipine + HCTZ

Primary Measures

• Change from baseline diastolic blood pressure after 8 weeks
• Change from baseline systolic blood pressure after 8 weeks

Secondary Measures

• 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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Principal Investigator Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00327587

Study ID Number: CVEA489A2302

ClinicalTrials.gov Identifier: NCT00327587

Health Authority: United States: Food and Drug Administration