Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients (TRAIL)
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...
Brief Summary
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)”
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.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: June 2005
Intervention(s) in this Clinical Trial
- 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).
Arms, Groups and Cohorts in this Clinical Trial
- Other: 1
- Other: 2
- Other: 3
Outcome Measures for this Clinical Trial
Primary Measures
- Effectiveness of escalating dose regimen of trandolapril in controlling blood pressure
- Time Frame: 14 weeks
Safety Issue?: No
- Time Frame: 14 weeks
Secondary Measures
- Changes in blood pressure, safety.
- Time Frame: 14 and 26 weeks
Safety Issue?: Yes
- Time Frame: 14 and 26 weeks
- BP mmHg incremental and absolute change
- Time Frame: 14 and 26 weeks
Safety Issue?: Yes
- Time Frame: 14 and 26 weeks
- Adverse events
- Time Frame: Throughout 26 weeks
Safety Issue?: Yes
- Time Frame: Throughout 26 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Stage 1 or 2 Hypertension
Exclusion Criteria:
- Uncontrolled diabetes
- Subject has a hypersensitivity to ACE inhibitor
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Abbott Industry
Overall Clinical Trial Officials and Contacts
Global Medical Information 1-800-633-9110 Study Director Abbott
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00233532
Study ID Number: CANA-03-003
ClinicalTrials.gov Identifier: NCT00233532
Health Authority: Canada: Ethics Review Committee
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00233532
