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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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
Experimental: 1	Drug: trandolapril/verapamil 180/2 mg QD Other Names: ABT-TARKA trandolapril/verapamil Tarka

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

Keywords provided by Abbott:

Hypertension
Tarka

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Verapamil
Diltiazem
Trandolapril
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

Pharmacologic Actions
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012