A Year Long Study to Evaluate the Safety of the Combination of Valsartan (320 mg) and Amlodipine (5 mg) in Patients With Hypertension - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00170976

Purpose

A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2307.

Condition	Intervention	Phase
Hypertension	Drug: valsartan + amlodipine	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Valsartan Amlodipine Amlodipine besylate

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A 54 Week, Extension to the Double-Blind, Multicenter, Multifactorial, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Valsartan (160 mg and 320 mg) and Amlodipine (10 mg) Combined and Alone in Hypertensive Patients

Further study details as provided by Novartis:

Primary Outcome Measures:

Adverse events and serious adverse events at each study visit for 6 or 12 months

Secondary Outcome Measures:

Change from baseline in diastolic blood pressure from baseline after 6 or 12 months
Change from baseline in systolic blood pressure from baseline after 6 or 12 months
Change from baseline in standing diastolic and systolic blood pressure after 6 or 12 months
Change from baseline in sitting and standing pulse after 6 or 12 months
Hematology and blood chemistry after 6 or 12 months

Estimated Enrollment:	403
Study Start Date:	April 2004

Eligibility

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

Criteria

Inclusion Criteria:

Exclusion Criteria:

PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2307 CORE

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170976

Locations

Germany
Sites in germany
Investigative Centers, Germany
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Study ID Numbers:	CVAA489A2307E1
Study First Received:	September 10, 2005
Last Updated:	July 6, 2007
ClinicalTrials.gov Identifier:	NCT00170976
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

HYPERTENSION, VALSARTAN, AMLODIPINE< SAFETY

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