Effectiveness of a Valsartan Based vs an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: March 16, 2006
Last updated: November 7, 2011
Last verified: November 2011

Essential hypertension is a widespread disease which affects one out of every three adults in the industrialized world. It contributes to cardiovascular disease development, a major and well established risk factor. A patient non compliant to drug therapy is recognized as one of the primary reasons for inadequate blood pressure control.

Condition Intervention Phase
Drug: valsartan
Drug: amlodipine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: An 8 Week Extension to a Randomized, Double-blind, Parallel Group, Active-controlled, Multi-center, 14 Week Study to Evaluate the Effectiveness of a Valsartan Versus and Amlodipine Treatment Strategy in Achieving Blood Pressure Control in Patients With Stage 1 or Stage 2 Hypertension or Uncontrolled on Present Monotherapy

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of patients who reach BP goal, systolic <140 mmHg and diastolic <90 mmHg, after 22 weeks

Secondary Outcome Measures:
  • Percentage of patients who reach BP goal, systolic <140 mmHg and diastolic <90 mmHg, after 14 and 22 weeks
  • Adverse events after 22 weeks

Enrollment: 79
Study Start Date: June 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both

Inclusion criteria

  • MSSBP> 140 mm Hg, and/or MSDBP> 90 mm Hg and currently treated with either valsartan 320 mg/ HCTZ 25 mg or amlodipine 10 mg/HCTZ 25 mg at end of core study

Exclusion criteria

  • Premature discontinuation in the core study or failure to comply with the core study protocol
  • Any patient that the investigator decides should not participate in the extension

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00351130

Investigative Centers, Germany
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novatis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00351130     History of Changes
Other Study ID Numbers: CVAH631B2406E1
Study First Received: March 16, 2006
Last Updated: November 7, 2011
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Novartis:
stage 1 hypertension,
stage 2 hypertension,

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on April 16, 2014