Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients (TRAIL) - Full Text View

Purpose

The TRAIL study was conducted to examine the effects of escalating doses of an ACE inhibitor, trandolapril, on lowering blood pressure in Stage 1-2 hypertensive patients.

Condition	Intervention	Phase
Hypertension	Drug: Trandolapril	Phase IV

MedlinePlus related topics:

High Blood Pressure

ChemIDplus related topics:

Diltiazem Verapamil Dexverapamil Diltiazem hydrochloride Diltiazem malate Verapamil hydrochloride Trandolapril

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Prospective, Open-Label Study to Evaluate the Effect of an Escalating Dose Regimen of Trandolapril on Blood Pressure in Treatment-Naïve and Concurrently Treated Hypertensive Patients (TRAIL)

Further study details as provided by Abbott:

Primary Outcome Measures:

Effectiveness of escalating dose regimen of trandolapril in controlling blood pressure [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in blood pressure, safety. [ Time Frame: 14 and 26 weeks ] [ Designated as safety issue: Yes ]
BP mmHg incremental and absolute change [ Time Frame: 14 and 26 weeks ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: Throughout 26 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	2000
Study Start Date:	March 2004
Estimated Study Completion Date:	September 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Drug: Trandolapril 0.5, 1,2,4mg/once daily/ for 26 weeks (If BP was not controlled, dose was escalated to the next higher dosage every 4-5 weeks).
2	Drug: Trandolapril 0.5, 1,2,4mg/once daily/ for 26 weeks (If BP was not controlled, dose was escalated to the next higher dosage every 4-5 weeks).
3	Drug: Trandolapril 0.5, 1,2,4mg/once daily/ for 26 weeks (If BP was not controlled, dose was escalated to the next higher dosage every 4-5 weeks).

Eligibility

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

Criteria

Inclusion Criteria:

Stage 1 or 2 Hypertension

Exclusion Criteria:

Uncontrolled diabetes
Subject has a hypersensitivity to ACE inhibitor

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233532

Sponsors and Collaborators

Abbott

Investigators


Study Director:	Global Medical Information 1-800-633-9110	Abbott

More Information

Responsible Party:	Abbott ( Anita Vanjaka, Clinical Research Manager )
Study ID Numbers:	CANA-03-003
First Received:	September 13, 2005
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00233532
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Abbott:

Hypertension

Trandolapril

Study placed in the following topic categories:

Trandolapril

Verapamil

Diltiazem

Vascular Diseases

Hypertension

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Angiotensin-Converting Enzyme Inhibitors

Enzyme Inhibitors

Cardiovascular Diseases

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

Protease Inhibitors

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00233532