A Year Long Study to Evaluate the Safety of the Combination of Valsartan (320 mg) and Amlodipine (5 mg) in Patients With Hypertension

Overview

A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2307.

Full Title of Study: “A 54 Week, Extension to the Double-blind, Multicenter, Multifactorial, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Valsartan (160 mg and 320 mg) and Amlodipine (10 mg) Combined and Alone in Hypertensive Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2005

Interventions

  • Drug: valsartan + amlodipine

Clinical Trial Outcome Measures

Primary Measures

  • Adverse events and serious adverse events at each study visit for 6 or 12 months

Secondary Measures

  • Change from baseline in diastolic blood pressure from baseline after 6 or 12 months
  • Change from baseline in systolic blood pressure from baseline after 6 or 12 months
  • Change from baseline in standing diastolic and systolic blood pressure after 6 or 12 months
  • Change from baseline in sitting and standing pulse after 6 or 12 months
  • Hematology and blood chemistry after 6 or 12 months

Participating in This Clinical Trial

Inclusion Criteria

  • SUCCESSFUL COMPLETION OF VAA489A2307 CORE TRIAL – VISIT 7 BLOOD PRESSURE MUST BE MSDBP ≤ 95 mmHg AND MSSBP ≤ 150 mmHg Exclusion Criteria:

  • PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2307 CORE Other protocol-defined exclusion criteria may apply.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

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

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