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

This study has been completed.

First Received on September 10, 2005. Last Updated on November 7, 2011 History of Changes

Sponsor:	Novartis
Information provided by (Responsible Party):	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

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:

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

Enrollment:	1018
Study Start Date:	October 2004
Study Completion Date:	June 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

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

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sinkiewicz W, Glazer RD, Kavoliuniene A, Miglinas M, Prak H, Wernsing M, Yen J. Efficacy and tolerability of amlodipine/valsartan combination therapy in hypertensive patients not adequately controlled on valsartan monotherapy. Curr Med Res Opin. 2009 Feb;25(2):315-24.

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00170963 History of Changes
Other Study ID Numbers:	CVAA489A2305
Study First Received:	September 10, 2005
Last Updated:	November 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension, high blood pressure, valsartan, amlodipine

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Valsartan
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on February 09, 2012