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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014