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Study of Verinurad in Heart Failure With Preserved Ejection Fraction

NCT04327024 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2023-06-29

Study results available
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Summary

International, Multicenter, Double-Blind, Placebo and Active Control Efficacy and Safety Study to Evaluate Verinurad combined with Allopurinol in Heart Failure with Preserved Ejection Fraction

Conditions

  • Heart Failure With Preserved Ejection Fraction (HFpEF)

Interventions

DRUG

Verinurad

The treatment will be titrated in 3 steps for target low dose (3 mg), intermediate dose (7.5 mg) and high dose (12mg) of verinurad. Drug: Allopurinol The treatment will be titrated in 3 steps. Low dose (100mg), intermediate (200mg) and high dose (300mg) of allopurinol.

DRUG

Allopurinol

Study treatments will be titrated in 3 steps: Low dose (100mg), intermediate (200mg) and high dose (300mg) of allopurinol

DRUG

Placebo for verinurad

Matching Capsule

DRUG

Placebo for allopurinol

Matching tablet

Sponsors & Collaborators

Principal Investigators

  • Dalane Kitzman, MD · 1326 Riverview Road Ext Lexington, NC 27292-1764 USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-19
Primary Completion
2022-04-29
Completion
2022-04-29
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Bulgaria
  • Canada
  • Germany
  • Mexico
  • Poland
  • Russia
  • Slovakia
  • South Korea

Study Locations

More Related Trials

Entities

Companies

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 NCT04327024 on ClinicalTrials.gov