Trials / Unknown
UnknownNCT00217178
Homocysteine Lowering and Atherosclerosis Reduction Trial (HART)
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 900 (planned)
- Sponsor
- Hamilton Health Sciences Corporation · Academic / Other
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
Summary
Study Objective: 1\. To evaluate whether combined therapy with folic acid 2.5 mg/day, vitamin B6 50 mg/day and vitamin B12 1000 micrograms/day vs placebo reduces the rate of atherosclerosis progression, as evaluated by quantitative B-mode carotid ultrasound (US).
Detailed description
The HART study is designed as a substudy of the Heart Outcomes Prevention Evaluation-2 (HOPE-2)trial which evaluates the effect of combined therapy ? folic acid and vitamin B6 and B12 on clinical events. The study is designed to enrol 900 study participants randomized to homocysteine lowering therapies or placebo. Follow-up will estimate over 5 years. Study participants will undergo yearly carotid B-Mode ultrasound examinations.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vitamins: Folic acid, B6, B12 |
Timeline
- Start date
- 2000-01-01
- Completion
- 2005-10-01
- First posted
- 2005-09-22
- Last updated
- 2005-09-22
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT00217178. Inclusion in this directory is not an endorsement.