EXforge As Compared to Losartan Treatment in Stage 2 Systolic Hypertension - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00931710

Purpose

This study will compare the antihypertensive efficacy and safety of a valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2 systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and less than 200 mmHg.

Condition	Intervention	Phase
Stage 2 Systolic Hypertension	Drug: losartan, HCT, followed by valsartan, amlodipine, HCT Drug: valsartan, amlodipine, HCT	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title:	A 12-week Multicenter, Randomized, Double-blind, Parallel-group, Active-control Study to Evaluate the Antihypertensive Efficacy and Safety of an Exforge® (Valsartan/Amlodipine)-Based Regimen Versus a Losartan-based Regimen in Patients With Stage 2 Systolic Hypertension

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Losartan Losartan potassium Valsartan Exforge

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change in mean sitting systolic blood pressure [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in mean sitting diastolic blood pressure [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Proportion of patients achieving blood pressure control (defined as patients achieving mean sitting blood pressure less than 140 systolic and less than 90 diastolic [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: No ]
Proportion of treatment responders [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: No ]
Assessment of which treatment regimen achieves blood pressure control faster (blood pressure control [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Difference in change in mean sitting systolic and diastolic blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	460
Study Start Date:	July 2009
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Losartan-based regimen: Active Comparator	Drug: losartan, HCT, followed by valsartan, amlodipine, HCT daily
Valsartan/amlodipine-based regimen: Experimental	Drug: valsartan, amlodipine, HCT daily

Eligibility

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

Criteria

Inclusion Criteria:

Stage 2 systolic hypertension defined as office Mean Sitting Systolic blood pressure (BP) greater than 160 and less than 200 mmHg

Exclusion Criteria:

Office systolic blood pressure >200 and/or diastolic blood pressure >110 mmHg at Visit 1.
Use of four (4) or more antihypertensive medications within 30 days of Visit 1.
Refractory hypertension, defined as blood pressure >140/90 mmHg while taking three (3) drugs at the maximum dose of each drug, one of which must be a diuretic. (Therapy with a fixed-dose combination of two active medications represents two drugs).
Inability to safely discontinue all antihypertensive medications for 1-2 weeks prior to randomization.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931710

Contacts

Contact: Novartis Pharmaceuticals

862-778-8300

Locations

United States, Maryland
Health Trends Research, LLC	Recruiting
Baltimore, Maryland, United States
Contact: Novartis Pharmaceuticals 862-778-8300

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

862-778-8300

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CVEA489AUS01
Study First Received:	July 1, 2009
Last Updated:	September 14, 2009
ClinicalTrials.gov Identifier:	NCT00931710 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension
combination therapy
valsartan
cardiovascular diseases

Additional relevant MeSH terms:

Vasodilator Agents
Losartan
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Amlodipine
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Therapeutic Uses
Cardiovascular Diseases
Anti-Arrhythmia Agents
Valsartan
Hypertension

ClinicalTrials.gov processed this record on November 20, 2009