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NCT00283686 · ClinicalTrials.gov registry record · Phase 3
HALT Progression of Polycystic Kidney Disease Study A
A Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 3
- Development phase
- 558
- Enrollment target
NCT00283686 is a Phase 3 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 558 participants.
The verdict
NCT00283686, a Phase 3 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 558 participants
- Enrollment target
Study Summary
The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD) will be assessed in two multicenter randomized clinical trials targeting different levels of kidney function: 1) early disease defined by GFR \>60 mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73 m2 (Study B; NCT01885559). Participants will be recruited and enrolled, either to Study A or B, over the first three years. Participants enrolled in Study A will be followed for at least 5 years, while those enrolled in Study B will be followed for five-to-eight years, with the average length of follow-up being six and a half years. The two concurrent randomized clinical trials differ by eligibility criteria, interventions and outcomes to be studied.
Interventions
- DRUG Placebo
- DRUG Telmisartan
- DRUG Lisinopril
- OTHER Standard Blood Pressure Control
- OTHER Low Blood Pressure Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 558 participants |
| Start Date | 2006-01 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00283686
The ClinicalTrials.gov registry entry for NCT00283686 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 558 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00283686 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00283686 about?
NCT00283686 is a clinical study titled "HALT Progression of Polycystic Kidney Disease Study A". The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD) will be assessed in two multicenter randomized clinical trials targeting different levels of kidney f...
What is the current status of trial NCT00283686?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 558 participants. The study started on 2006-01. Estimated completion is 2014-06.
What interventions are being tested in trial NCT00283686?
The interventions under investigation include: Placebo (DRUG), Telmisartan (DRUG), Lisinopril (DRUG), Standard Blood Pressure Control (OTHER), Low Blood Pressure Control (OTHER).
Who is sponsoring clinical trial NCT00283686?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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