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

Tracking Information

First Received Date ^ICMJE

March 20, 2008

Last Updated Date

May 19, 2009

Start Date ^ICMJE

January 2008

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00687973 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Amlodipine/Valsartan
Drug: Amlodipine

Study Arms / Comparison Groups

Amlodipine/Valsartan: Experimental
Intervention: Drug: Amlodipine/Valsartan
Amlodipine: Active Comparator
Intervention: Drug: Amlodipine

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

474

Completion Date

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00687973

Responsible Party

External Affairs, Novartis Pharmaceuticals

Study ID Numbers ^ICMJE

CVAA489AFR02

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP