Russian Study of the Efficacy and Safety of Tarka in Patients With Hypertension - Full Text View

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00235001

Purpose

This study will investigate antihypertensive activity and safety profile of Tarka in Russian hypertension patients by ambulatory blood pressure measurement (ABPM)

Condition	Intervention	Phase
Hypertension	Drug: trandolapril/verapamil	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Open, Phase IV, 24-Hour Ambulatory Blood Pressure Monitoring Study of the Efficacy and Safety of Tarka in Patients With Arterial Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Verapamil Diltiazem hydrochloride Dexverapamil Diltiazem Trandolapril Diltiazem malate Verapamil hydrochloride

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Change in blood pressure from baseline/blood pressure control [ Time Frame: Baseline to 3 months of Tx ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Absolute BP reduction from baseline, safety [ Time Frame: Baseline to 3 months of Tx ] [ Designated as safety issue: Yes ]

Enrollment:	120
Study Start Date:	June 2004
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: trandolapril/verapamil 180/2 mg QD

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hypertension

Exclusion Criteria:

SBP > 180 mm Hg, DBP > 114 mm Hg
Subject has a hypersensitivity to trandolapril or verapamil

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235001

Locations

United States, Illinois
Global Medical Information-Abbott
North Chicago, Illinois, United States, 60064

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Victor Gorin, MD

Abbott

More Information

No publications provided

Responsible Party:	Abbott ( Peter Bacher, MD, PhD )
Study ID Numbers:	RUSS-04-01
Study First Received:	September 13, 2005
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00235001 History of Changes
Health Authority:	Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Abbott:

Hypertension
Tarka

Additional relevant MeSH terms:

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

Membrane Transport Modulators
Trandolapril
Verapamil
Therapeutic Uses
Diltiazem
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Anti-Arrhythmia Agents
Hypertension

ClinicalTrials.gov processed this record on November 27, 2009