Efficacy, Safety and Tolerability of AZD9977 and Dapagliflozin in Participants With Heart Failure and Chronic Kidney Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Kidney Disease
- Heart Failure
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants who meet the eligibility criteria will be randomized to one of the following treatment group: AZD9977 Dose A + dapagliflozin 10 mg AZD9977 Dose B + dapagliflozin 10 mg AZD9977 Dose C + dapagliflozin 10 mg AZD9977 Dose C Dapagliflozin 10 mg Placebo Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 130 years
- Gender
- Both males and females
Description
The study will be conducted in approximately 140 sites in about 12 countries. After screening, eligible participants will undergo a 3 to 4-week run-in period to ensure washout of prior medications. At the end of the run-in period, eligible participants will be randomly assigned with a 1:1:1:1:1:1 ra...
The study will be conducted in approximately 140 sites in about 12 countries. After screening, eligible participants will undergo a 3 to 4-week run-in period to ensure washout of prior medications. At the end of the run-in period, eligible participants will be randomly assigned with a 1:1:1:1:1:1 ratio to receive once daily administration of one of the following study treatments group for 12 weeks: AZD9977 Dose A + dapagliflozin 10 mg AZD9977 Dose B + dapagliflozin 10 mg AZD9977 Dose C + dapagliflozin 10 mg AZD9977 Dose C Dapagliflozin 10 mg Placebo Participants will be randomized to one of the above treatment group, according to T2DM (yes/no) and eGFR (<30 mL/min / ? 30 to ? 45 mL/min / >45 mL/min). The total duration of participation will be approximately 19 to 21 weeks.
Tracking Information
- NCT #
- NCT04595370
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: John McMurray University of Glasgow, United Kingdom