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NCT02228408 · ClinicalTrials.gov registry record · Phase 4
Safety and Cardiovascular Efficacy of Hydralazine and Isosorbide Dinitrate in Dialysis-Dependent ESRD
A Phase 4 study of Chronic Hemodialysis (ESRD), sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT02228408: Completed Phase 4 study of Chronic Hemodialysis (ESRD), sponsored by Brigham and Women's Hospital.
NCT02228408 is a Phase 4 study of Chronic Hemodialysis (ESRD) that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 17 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02228408, a Phase 4 study of Chronic Hemodialysis (ESRD), has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a pilot study designed to compare the safety and cardiovascular effects of 26 weeks of combination hydralazine/isorsorbide dinitrate therapy with placebo therapy in patients receiving chronic hemodialysis. The investigators hypothesize that treatment of chronic hemodialysis (ESRD) patients with a combination of hydralazine/isosorbide dinitrate compared with placebo is safe and that it will improve heart function as well blood flow/blood vessel supply.
Primary Outcome
Rate of primary Safety Outcomes(hypotension, serious adverse events, GI events and CV death)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Hydralazine/Isorsorbide Dinitrate
Study Locations (1)
Massachusetts
- Brigham & Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2017-08-28 |
| Est. Completion | 2019-05-07 |
| Phase | Phase 4 |
What the finished NCT02228408 record still lists
NCT02228408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Chronic Hemodialysis (ESRD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02228408 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02228408 about?
NCT02228408 is a clinical study titled "Safety and Cardiovascular Efficacy of Hydralazine and Isosorbide Dinitrate in Dialysis-Dependent ESRD". This study is a pilot study designed to compare the safety and cardiovascular effects of 26 weeks of combination hydralazine/isorsorbide dinitrate therapy with placebo therapy in patients receiving chronic hemodialysis. The investigators hypothesize that treatment of chronic hemodialysis (ESRD) pat...
What is the current status of trial NCT02228408?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2017-08-28. Estimated completion is 2019-05-07.
What conditions does trial NCT02228408 study?
This clinical trial studies the following conditions: Chronic Hemodialysis (ESRD).
What interventions are being tested in trial NCT02228408?
The interventions under investigation include: Placebo (DRUG), Hydralazine/Isorsorbide Dinitrate (DRUG).
Who is sponsoring clinical trial NCT02228408?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02228408 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02228408's enrollment target sits among peer trials
17 1855th of 2000 higher than 132 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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