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Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients (TRAIL)

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00233532
First received: September 13, 2005
Last updated: July 18, 2008
Last verified: July 2008
History of Changes
  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 4

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 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)

Resource links provided by NLM:

U.S. FDA Resources

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
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).
Other Names:
  • ABT-TARKA
  • trandolapril/verapamil
  • TARKA
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).
Other Names:
  • ABT-TARKA
  • trandolapril/verapamil
  • TARKA
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).
Other Names:
  • ABT-TARKA
  • trandolapril/verapamil
  • TARKA

  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

No publications provided

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

Keywords provided by Abbott:
Hypertension
Trandolapril

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Trandolapril
Verapamil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on May 16, 2013