A Study to Evaluate the Combination of Valsartan + Amlodipine in Hypertensive Patients

This study has been completed.

First Received: October 23, 2006 Last Updated: July 6, 2007 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00392262

Purpose

The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with amlodipine or felodipine alone.

Condition	Intervention	Phase
Hypertension	Drug: valsartan + amlodipine	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Valsartan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Multicenter Study to Evaluate the Efficacy and Tolerability of a 4-Week Therapy With the Combination of Valsartan 160mg + Amlodipine 5mg in Hypertensive Patients Not Adequately Responding to 4-Week Treatment With Amlo 5mg or Felodipine 5mg in Monotherapy

Further study details as provided by Novartis:

Primary Outcome Measures:

To investigate whether 4 weeks treatment with valsartan 160mg + amlo 5mg provide an add'l mean sitting systolic blood pressure reduction in patients not adequately responding to 4 weeks treatment with amlo 5mg or felodipine 5mg

Secondary Outcome Measures:

Mean sitting diastolic blood pressure (analogously & explorative)
Normalization (analogously & explorative)
Responder rate. (analogously & explorative)

Estimated Enrollment:	230
Study Start Date:	August 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Male or female patients (18 years)
Patients with moderate essential hypertension (untreated must have MSSBP ≥160 and <180 mmHg at Visit 1, treated must have MSSBP <180 mmHg at Visit 1) (WHO grade II)

Exclusion Criteria:

Severe hypertension(MSDBP ≥110 mmHg or MSSBP ≥ 180 mmHg)
Pregnant or nursing women
Treated hypertensive patients with controlled hypertension under current therapy (diastolic BP < 90 mmHg and systolic BP < 140 mmHg)
A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392262

Locations

Germany

Investigative Centers, Germany
Switzerland
Novartis
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis +41 61 324 1111

Novartis

More Information

No publications provided

Study ID Numbers:	CVAA489ADE03
Study First Received:	October 23, 2006
Last Updated:	July 6, 2007
ClinicalTrials.gov Identifier:	NCT00392262 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Moderate essential hypertension (WHO grade II)

Study placed in the following topic categories:

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

Antihypertensive Agents
Felodipine
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 May 07, 2009