Trials / Completed
CompletedNCT03877224
DETERMINE-preserved - Dapagliflozin Effect on Exercise Capacity Using a 6-minute Walk Test in Patients With Heart Failure With Preserved Ejection Fraction
International, Multicentre, Parallel-group, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the Effect of Dapagliflozin on Exercise Capacity in Heart Failure Patients With Preserved Ejection Fraction
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 504 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 40 Years – 150 Years
- Healthy volunteers
- Not accepted
Summary
International, Multicentre, Parallel-group, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the effect of Dapagliflozin on Exercise Capacity in Heart Failure Patients with Preserved Ejection Fraction (HFpEF)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dapagliflozin | Tablets administered orally once daily. Treatment start within 24h after randomisation for 16 weeks. |
| OTHER | Placebo | Tablets administered orally once daily. Treatment start within 24h after randomisation for 16 weeks. |
Timeline
- Start date
- 2019-04-04
- Primary completion
- 2020-07-09
- Completion
- 2020-07-09
- First posted
- 2019-03-15
- Last updated
- 2021-11-17
- Results posted
- 2021-11-17
Locations
101 sites across 12 countries: United States, Argentina, Brazil, Bulgaria, Canada, Denmark, Italy, Japan, Slovakia, South Africa, South Korea, Sweden
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03877224. Inclusion in this directory is not an endorsement.