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NCT00032435 · ClinicalTrials.gov registry record · Phase 3
Homocysteine Study (HOST)
A Phase 3 study, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,003
- Enrollment target
NCT00032435 is a Phase 3 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 2,003 participants.
The verdict
NCT00032435, a Phase 3 study, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,003 participants
- Enrollment target
Study Summary
The primary objective of this study is to test the hypothesis that administration of folate, pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) in high doses to patients with advanced chronic renal failure or end stage renal disease and abnormally high plasma homocysteine levels will lower the homocysteine levels and the death rate compared to patients who receive placebo. The secondary objective is to test the hypothesis that intake of the vitamins compared to placebo decreases the incidence of myocardial infarction, disabling stroke, and amputation of a lower extremity and, in hemodialysis patients, thrombosis of the vascular access.
Interventions
- DRUG PAL-40 Active
- DRUG PAL-40 Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,003 participants |
| Start Date | 2001-05 |
| Est. Completion | 2006-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00032435
The ClinicalTrials.gov registry entry for NCT00032435 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,003 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which PAL-40 Active is the first listed.
NCT00032435 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00032435 about?
NCT00032435 is a clinical study titled "Homocysteine Study (HOST)". The primary objective of this study is to test the hypothesis that administration of folate, pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) in high doses to patients with advanced chronic renal failure or end stage renal disease and abnormally high plasma homocysteine levels will lower the...
What is the current status of trial NCT00032435?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,003 participants. The study started on 2001-05. Estimated completion is 2006-09.
What interventions are being tested in trial NCT00032435?
The interventions under investigation include: PAL-40 Active (DRUG), PAL-40 Placebo (DRUG).
Who is sponsoring clinical trial NCT00032435?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
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