Effectiveness of a Valsartan Based Versus 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.

First Received: March 16, 2006 Last Updated: August 13, 2007 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00304226

Purpose

The population for this current study will include stage 1 and stage 2 hypertensive patients who are newly diagnosed or didn't have treatment during the last 3 months and patients who are currently treated but uncontrolled on present monotherapy. The purpose of this study is to evaluate the efficacy of a treatment with valsartan versus a treatment with amlodipine in reaching blood pressure control after 14 weeks of treatment.

Condition	Intervention	Phase
Hypertension	Drug: valsartan Drug: amlodipine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 14 Week Study to Evaluate Effectiveness of a Valsartan Versus an 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:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Blood pressure less than 140/90 mmHg after 14 weeks

Secondary Outcome Measures:

Blood pressure less than 140/90 mmHg after 4, 8, and 11 weeks
Blood pressure less than 140/90 mmHg after 4, 8, 11, and 14 weeks
Time when blood pressure reaches less than 140/90 mmHg
Change in blood pressure at baseline, week 4, 8, 11, and 14
Adverse events and serious adverse events at each study visit for 14 weeks

Estimated Enrollment:

1244

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria

Stage/grade 1 or stage/ grade 2 hypertension, MSSBP ≥ 140 mm Hg, and/ or MSDBP ≥ 90 mm Hg, at Visit 1 and 2 in untreated patients
Or Patients who are currently treated on monotherapy and uncontrolled and have a blood pressure ≤ 160/100 mm Hg at Visit 1 and Visit 2

Exclusion criteria

Current treatment with a CCB
MSSBP ≥ 180 mm Hg or MSDBP ≥ 110 mm Hg at any time between visit 1 and Visit 2
History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
Evidence of a secondary form of hypertension
Cerebrovascular accident or myocardial infarction during the last 12 months, prior to Visit 1 Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304226

Locations

Germany

Investigative Centers, Germany
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

Novatis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CVAH631B2406
Study First Received:	March 16, 2006
Last Updated:	August 13, 2007
ClinicalTrials.gov Identifier:	NCT00304226 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Novartis:

Valsartan,
amlodipine,
hydrochlorothiazide

Study placed in the following topic categories:

Calcium, Dietary
Vasodilator Agents
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents

Antihypertensive Agents
Hydrochlorothiazide
Valsartan
Amlodipine
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Amlodipine
Membrane Transport Modulators
Therapeutic Uses
Cardiovascular Diseases
Valsartan
Hypertension

ClinicalTrials.gov processed this record on August 24, 2009