Trials / Terminated
TerminatedNCT03292653
Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure
An Exploratory, Randomized, Double-blind, Placebo-controlled, Parallel Arm Trial of the Safety and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Patients Hospitalized With Worsening Heart Failure
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Lexicon Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objectives: * Assess the safety and tolerability of sotagliflozin in hemodynamically stable participants with worsening of heart failure, compared to placebo. * Estimate the effects of sotagliflozin on plasma volume changes in hemodynamically stable participants with worsening of heart failure, compared to placebo. Secondary Objectives: * Explore the effect of sotagliflozin on erythropoiesis, as assessed by changes in plasma erythropoietin levels, in hemodynamically stable participants with worsening of heart failure, compared to placebo. * Explore the effect of sotagliflozin on changes in plasma N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels, in hemodynamically stable participants with worsening of heart failure, compared to placebo.
Detailed description
The total study duration will be approximately 27-40 days, including a screening period of 1-10 days, a treatment period of 14 days, and a follow-up period of 14±2 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sotagliflozin | Pharmaceutical form: Tablet; Route of administration: Oral |
| DRUG | Placebo | Pharmaceutical form: Tablet; Route of administration: Oral |
Timeline
- Start date
- 2017-12-04
- Primary completion
- 2019-08-17
- Completion
- 2019-08-17
- First posted
- 2017-09-25
- Last updated
- 2021-05-11
- Results posted
- 2021-05-11
Locations
6 sites across 3 countries: United States, Canada, Netherlands
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03292653. Inclusion in this directory is not an endorsement.