NCT03254485

A Study of the Effect of IW-1973 on the Exercise Capacity of Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Safety and Efficacy of Different Doses of IW-1973 Over 12 Weeks in Patients With Heart Failure With Preserved Ejection Fraction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Akebia Therapeutics · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The objective of the CAPACITY-HFpEF study is to evaluate the safety and efficacy of IW-1973 compared with placebo when administered daily for approximately 12 weeks to patients with HFpEF. The study will evaluate the effect of oral IW-1973 on peak exercise capacity in patients with HFpEF, with or without permanent or persistent atrial fibrillation.

Conditions

• Heart Failure With Preserved Ejection Fraction

Interventions

Type	Name	Description
DRUG	IW-1973	Oral Tablet
DRUG	Placebo Oral Tablet	Oral Tablet

Timeline

• Start date: 2017-11-07
• Primary completion: 2019-08-19
• Completion: 2019-08-19
• First posted: 2017-08-18
• Last updated: 2022-09-15
• Results posted: 2022-09-15

Locations

62 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study