Efficacy and Safety of Valsartan/Amlodipine Combination in Patients With Severe Hypertension

This study has been completed.

First Received: September 12, 2005 Last Updated: June 1, 2006 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171535

Purpose

This study will assess the effectiveness and safety of different combination antihypertensive treatments in patients with severe hypertension

Condition	Intervention	Phase
Hypertension	Drug: valsartan/amlodipine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study to Evaluate the Safety and Efficacy of Valsartan/Amlodipine Compared to Lisinopril/Hydrochlorothiazide Given Once Daily for 6 Weeks is Patients With Severe Hypertension

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:

Adverse events and serious adverse events at each study visit for 6 weeks

Secondary Outcome Measures:

Sitting and standing blood pressure measurements after 6 weeks
Laboratory test data after 6 weeks
Vital signs at each study visit for 6 weeks

Estimated Enrollment:	130
Study Start Date:	October 2004

Eligibility

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

Criteria

Inclusion Criteria:

Patients with severe hypertension

Exclusion Criteria:

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 inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171535

Locations

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CVAA489A2308
Study First Received:	September 12, 2005
Last Updated:	June 1, 2006
ClinicalTrials.gov Identifier:	NCT00171535 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

hypertension
high blood pressure
valsartan
amlodipine

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 February 08, 2010