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NCT03315143 · ClinicalTrials.gov registry record · Phase 3
Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
A Phase 3 study, sponsored by Lexicon Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 10,584
- Enrollment target
NCT03315143 is a Phase 3 study that was terminated before completion, run by Lexicon Pharmaceuticals. The registered enrollment target is 10,584 participants.
The verdict
NCT03315143, a Phase 3 study, was terminated before completion, sponsored by Lexicon Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 10,584 participants
- Enrollment target
Study Summary
The primary objective of the study was to compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure \[HHF\], and urgent visit for heart failure \[HF\] in participants with type 2 diabetes, cardiovascular risk factors, and moderate to severely impaired renal function.
Interventions
- DRUG Placebo
- DRUG Sotagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,584 participants |
| Start Date | 2017-12-19 |
| Est. Completion | 2020-07-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03315143
The ClinicalTrials.gov registry entry for NCT03315143 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 10,584 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lexicon Pharmaceuticals, which has 56 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03315143 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03315143 about?
NCT03315143 is a clinical study titled "Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk". The primary objective of the study was to compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure \[HHF\], and urgent visit for heart failure \[HF\] in participants with type 2 diabetes, cardiovascular risk factors, and mode...
What is the current status of trial NCT03315143?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 10,584 participants. The study started on 2017-12-19. Estimated completion is 2020-07-08.
What interventions are being tested in trial NCT03315143?
The interventions under investigation include: Placebo (DRUG), Sotagliflozin (DRUG).
Who is sponsoring clinical trial NCT03315143?
This trial is sponsored by Lexicon Pharmaceuticals, which has 56 total clinical trials registered on ClinicalTrials.gov.
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