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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: August 2007

Interventions

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

Clinical Trial Outcome Measures

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

Participating in This Clinical Trial

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: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Novartis
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Principal Investigator, Novartis Pharmaceuticals

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