Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5mg

This study has been completed.

First Received: March 20, 2008 Last Updated: May 19, 2009 History of Changes

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00687973

Purpose

Assess that for an equivalent brachial BP lowering, a fixed dose combination Amlodipine/Valsartan based regimen reduces central aortic BP pressure to a larger extent than an atenolol/amlodipine combination based regimen

Condition	Intervention	Phase
Hypertension	Drug: Amlodipine/Valsartan Drug: Amlodipine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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:

central SBP measured at carotid artery level ( assessed with Sphygmocor system, Atcor Medical, Sydney, Australia) : difference in reduction of central SBP at baseline and at 24 weeks between the two arms [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

central pressure assessed with Sphygmocor system (Atcor Medical, Sydney, Australia) [ Time Frame: Baseline, 8 weeks, 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	474
Study Start Date:	January 2008
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Amlodipine/Valsartan: Experimental	Drug: Amlodipine/Valsartan
Amlodipine: Active Comparator	Drug: Amlodipine

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female patients 18 years of age or older
Hypertension defined by MSDBP > 90 and or MSSBP >140 mmHg, MSDBP > 80mmHg, or/and MSSBP> 130mmHg if diabetes or chronic renal impairment uncontrolled under their previous therapy, or untreated , or experiencing unacceptable side effects
Written informed consent to participate in the study prior to any study procedures

Exclusion Criteria:

Severe hypertension (grade 3 WHO classification MSDBP > 110 mmHg and/or MSSBP >180 mmHg)
Evidence of a secondary form of hypertension
Type 1 diabetes mellitus
History of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687973

Locations

France
2 & 4 rue Lionel Terray BP 308
Rueil-Malmaison, France, 92506

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CVAA489AFR02
Study First Received:	March 20, 2008
Last Updated:	May 19, 2009
ClinicalTrials.gov Identifier:	NCT00687973 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: Ministry of Health

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