Efficacy and Safety of the Combination of Valsartan Plus Amlodipine in Hypertensive Patients Not Adequately Responding to the Combination Therapy With Ramipril Plus Felodipine

This study has been completed.

First Received on August 22, 2006. Last Updated on November 7, 2011 History of Changes

Sponsor:	Novartis
Information provided by (Responsible Party):	Novartis
ClinicalTrials.gov Identifier:	NCT00367939

Purpose

The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with ACE inhibitor plus calcium channel blocker

Condition	Intervention	Phase
Hypertension	Drug: valsartan + amlodipine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Multicenter Study to Evaluate the Efficacy and Safety of a 5 Week Therapy With the Combination of Valsartan 160 mg Plus Amlodipine 10 mg in Hypertensive Patients Not Adequately Responding to a 5 Week Therapy With Ramipril 5 mg and Felodipine 5 mg

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Felodipine Ramipril Amlodipine Amlodipine besylate Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

To investigate whether 5 weeks of treatment with valsartan 160mg + amlodipine 10mg provide add'l mean sitting systolic BP reduction in patients not adequately responding to 5 weeks of treatment with ramipril + felodipine--i.e., mean systolic BP

Secondary Outcome Measures:

To evaluate the effects of valsartan 160 mg plus amlodipine 10 mg on mean sitting diastolic BP, normalization and responder rate.

Enrollment:	132
Study Start Date:	December 2005
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (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:

Male or female patients (18 years or older)
Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. barrier method with spermicide, intra-uterine device, hormonal contraceptives).
Patients with moderate essential hypertension (WHO II)

Exclusion Criteria:

Severe hypertension
Pregnant or nursing women
Treated hypertensive patients with controlled hypertension under current therapy (MSDBP < 90 mmHg and MSSBP < 140 mmHg)
A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV
Other protocol-defined exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367939

Locations

Germany

Investigative Centers, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharma Ag

Novartis Pharmaceuticals

More Information

No publications provided by Novartis

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

Trenkwalder P, Schaetzl R, Borbas E, Handrock R, Klebs S. Combination of amlodipine 10 mg and valsartan 160 mg lowers blood pressure in patients with hypertension not controlled by an ACE inhibitor/CCB combination. Blood Press Suppl. 2008 Dec;2:13-21.

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00367939 History of Changes
Other Study ID Numbers:	CVAA489ADE01
Study First Received:	August 22, 2006
Last Updated:	November 7, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Hypertension

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Felodipine
Valsartan
Amlodipine
Ramipril
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on February 09, 2012