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.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00351130

Purpose

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
Hypertension	Drug: valsartan Drug: amlodipine	Phase IV

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Valsartan Amlodipine Amlodipine besylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Bio-equivalence Study
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

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

Estimated Enrollment:	1244
Study Start Date:	June 2006

Eligibility

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

Criteria

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

Locations

Germany

Investigative Centers, Germany
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

Novatis Pharmaceuticals

More Information

Study ID Numbers:	CVAH631B2406E1
Study First Received:	March 16, 2006
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00351130
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Novartis:

Hypertension,
stage 1 hypertension,
stage 2 hypertension,
valsartan,
amlodipine,

Study placed in the following topic categories:

Calcium, Dietary
Vascular Diseases
Valsartan
Amlodipine
Hypertension

Additional relevant MeSH terms:

Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Calcium Channel Blockers

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009