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

NCT03254485 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2022-09-15

Study results available
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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

Interventions

DRUG

IW-1973

Oral Tablet

DRUG

Placebo Oral Tablet

Oral Tablet

Sponsors & Collaborators

  • Cyclerion Therapeutics

    collaborator INDUSTRY
  • Akebia Therapeutics

    lead INDUSTRY

Principal Investigators

  • Jelena Seferovic, MD PhD · Cyclerion Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-07
Primary Completion
2019-08-19
Completion
2019-08-19
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03254485 on ClinicalTrials.gov