HypertensionPhase 4TRAILNCT00233532
Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients (TRAIL)
A Phase 4 study testing Trandolapril in people with Hypertension, run by Abbott.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Trandolapril
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Jun 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 1 or 2 Hypertension
Who cannot join
- Uncontrolled diabetes
- Subject has a hypersensitivity to ACE inhibitor
About this 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)
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.
- Conditions
- Hypertension
- Being tested
- Trandolapril
- Keywords
- Hypertension, Trandolapril
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrandolaprilDrug
Also called ABT-TARKA, trandolapril/verapamil, TARKA
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).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Drug: Trandolapril |
| 2 | Other | Not described Receives: Drug: Trandolapril |
| 3 | Other | Not described Receives: Drug: Trandolapril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of escalating dose regimen of trandolapril in controlling blood pressure
Measured: 14 weeks
Secondary outcomes (3)
Changes in blood pressure, safety.
Measured: 14 and 26 weeks
BP mmHg incremental and absolute change
Measured: 14 and 26 weeks
Adverse events
Measured: Throughout 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study startMar 2004
- Primary completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Medical Information 1-800-633-9110, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233532
- Sponsor's protocol ID
- CANA-03-003
- Acronym
- TRAIL
- Status last verified
- Jul 2008
- First submitted
- 13 Sep 2005
- Last updated
- 22 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00233532
- Acronym / sponsor ID
- TRAIL / CANA-03-003
- Conditions
- Hypertension
- Keywords
- Hypertension, Trandolapril
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Jun 2005 (actual)
- First posted
- 6 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Trandolapril |
| 2 | Other | Drug: Trandolapril |
| 3 | Other | Drug: Trandolapril |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stage 1 or 2 Hypertension
Key exclusion criteria (2 listed)
- Uncontrolled diabetes
- Subject has a hypersensitivity to ACE inhibitor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrandolaprilAlso: ABT-TARKA, trandolapril/verapamil, TARKA0.5, 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). | Drug | 1, 2, 3 |
Primary outcome
Effectiveness of escalating dose regimen of trandolapril in controlling blood pressure
Time frame: 14 weeks
3 secondary outcomes
Changes in blood pressure, safety.
Time frame: 14 and 26 weeks
BP mmHg incremental and absolute change
Time frame: 14 and 26 weeks
Adverse events
Time frame: Throughout 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Medical Information 1-800-633-9110 study director
Abbott
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trandolapril in people with Hypertension, run by Abbott.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of escalating dose regimen of trandolapril in controlling blood pressure (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2008.