Efficacy and Safety of Valsartan/Amlodipine Combination in Hypertensive Patients Not Controlled With Valsartan Alone

This study has been completed.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00170963

Purpose

This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication

Condition	Intervention	Phase
Hypertension	Drug: valsartan/amlodipine	Phase III

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, Safety/Efficacy Study
Official Title:	Valsartan/Amlodipine 160/5 mg or 160/10 mg Versus Valsartan 160 mg Alone for 8 Weeks in Hypertensive Patients Who Are Not Adequately Controlled on Valsartan 160 mg Monotherapy

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcome Measures:

Change from baseline in mean systolic blood pressure after 8 weeks
Decrease in diastolic blood pressure of at least 10 mmHg or diastolic blood pressure was less than 90 mmHg after 8 weeks
Diastolic blood pressure less than 90 mmHg after 8 weeks

Estimated Enrollment:	947
Study Start Date:	October 2004

Eligibility

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

Criteria

Inclusion Criteria:

Patients with uncomplicated, essential hypertension

Exclusion Criteria:

Severe hypertension
History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
Liver, kidney, or pancreas disease
Insulin dependent diabetes
Allergy to certain medications used to treat high blood pressure

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170963

Locations

Germany

Investigative Centers, Germany
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Study ID Numbers:	CVAA489A2305
Study First Received:	September 10, 2005
Last Updated:	November 13, 2006
ClinicalTrials.gov Identifier:	NCT00170963
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension, high blood pressure, 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 16, 2009