Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03521934 · ClinicalTrials.gov registry record · Phase 3
Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
A Phase 3 study, sponsored by Lexicon Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,222
- Enrollment target
NCT03521934 is a Phase 3 study that was terminated before completion, run by Lexicon Pharmaceuticals. The registered enrollment target is 1,222 participants.
The verdict
NCT03521934, a Phase 3 study, was terminated before completion, sponsored by Lexicon Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,222 participants
- Enrollment target
Study Summary
Primary Objective: To compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable participants after admission for worsening heart failure (WHF) Secondary Objectives: To compare the effects of sotagliflozin to placebo on: * The total occurrences of HHF and urgent visit for HF * The occurrence of CV death * The occurrence of all-cause mortality * The total occurrences of CV death, HHF, urgent visit for HF, non-fatal myocardial infarction (MI), and non-fatal stroke * Change in Kansas City Cardiomyopathy Questionnaire-12(KCCQ-12) score * Change in estimated glomerular filtration rate (eGFR)
Interventions
- DRUG Placebo
- DRUG Sotagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,222 participants |
| Start Date | 2018-06-15 |
| Est. Completion | 2020-06-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03521934
The ClinicalTrials.gov registry entry for NCT03521934 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1,222 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.
NCT03521934 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03521934 about?
NCT03521934 is a clinical study titled "Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)". Primary Objective: To compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable participants after admission for worsening heart failure (WHF) Seco...
What is the current status of trial NCT03521934?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,222 participants. The study started on 2018-06-15. Estimated completion is 2020-06-05.
What interventions are being tested in trial NCT03521934?
The interventions under investigation include: Placebo (DRUG), Sotagliflozin (DRUG).
Who is sponsoring clinical trial NCT03521934?
This trial is sponsored by Lexicon Pharmaceuticals, which has 56 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.