Long Term Study of Valsartan and Amlodipine in Patients With Essential Hypertension (Extension to Study CVAA489A1301) - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00446524

Purpose

The purpose of this study is to evaluate long-term safety and tolerability of once daily administration of the combination of Valsartan and Amlodipine 80/5 mg for 52 weeks in patients with essential hypertension.

Condition	Intervention	Phase
Hypertension	Drug: Valsartan + Amlodipine besilate	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Valsartan Amlodipine Amlodipine besylate Exforge

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A 54-Week Extension to the Multi-Center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Factorial Study to Evaluate the Efficacy and Safety of VAA489 (Valsartan and Amlodipine Combined) and Alone in Essential Hypertensive Patients - Long Term Study of VAA489 in Patients With Essential Hypertension (Extension From A1301 Study)

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety assessed by serious and non-serious adverse events

Secondary Outcome Measures:

Efficacy assessed by the changes-from baseline measurements in mean sitting diastolic blood pressure, mean sitting systolic blood pressure, standing diastolic blood pressure, and standing systolic blood pressure
Laboratory tests
Vital signs
Electrocardiogram (ECG)

Estimated Enrollment:	400
Study Start Date:	February 2007

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participation in study CVAA489A1301
Patients whose blood pressure at Visit 7 of the Study CVAA489A1301 trial was well controlled
Outpatients

Exclusion Criteria:

Presence of major protocol violation in Study CVAA489A1301
Patients who experienced any adverse events considered serious and drug related in Study CVAA489A1301

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446524

Locations

Japan
Novartis Investigative Site
Fukuoka, Japan

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CVAA489A1302
Study First Received:	March 9, 2007
Last Updated:	October 16, 2007
ClinicalTrials.gov Identifier:	NCT00446524
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

Hypertension, Valsartan, Amlodipine, high blood pressure

Study placed in the following topic categories:

Calcium, Dietary
Vascular Diseases
Essential hypertension

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