Overview

This trial is active, not recruiting.

Condition heart failure
Treatments vericiguat (bay1021189) (1.25 mg), vericiguat (bay1021189) (5 mg), placebo
Phase phase 2
Sponsor Bayer
Start date November 2013
End date August 2015
Trial size 476 participants
Trial identifier NCT01951638, 15829, 2013-002288-25

Summary

Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard diuretic and comorbidity treatment for heart failure with preserved ejection fraction (HFpEF)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
2.5 mg orally once daily for 2 weeks, up-titration to 5 mg orally once daily for 2 weeks, up-titration to 10 mg orally once daily for 8 weeks
vericiguat (bay1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
vericiguat (bay1021189) (5 mg)
5 mg BAY1021189 tablets
(Experimental)
2.5 mg orally once daily for 2 weeks, then 5 mg orally once daily for 10 weeks (with sham titration)
vericiguat (bay1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
vericiguat (bay1021189) (5 mg)
5 mg BAY1021189 tablets
(Experimental)
2.5 mg orally once daily for 12 weeks (with sham titrations)
vericiguat (bay1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
(Experimental)
1.25 mg orally once daily for 12 weeks (with sham titrations)
vericiguat (bay1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
(Placebo Comparator)
Orally once daily for 12 weeks (with sham titrations)
placebo

Primary Outcomes

Measure
Change of log-transformed N-terminal pro-brain natriuretic peptide (NT-proBNP)
time frame: Baseline and 12 weeks
Change of left atrial volume (LAV)
time frame: Baseline and 12 weeks

Secondary Outcomes

Measure
Number of participants with adverse events as a measure of safety and tolerability
time frame: Up to 4 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Worsening chronic heart failure (WCHF) requiring hospitalization (or intravenous diuretic treatment for HF without hospitalization) with initiation of study treatment after clinical stabilization - Left ventricular ejection fraction (LVEF) >/= 45% by echocardiography at randomization Exclusion Criteria: - Intravenous inotropes at any time after hospitalization

Additional Information

Official title A Randomized Parallel-group, Placebo-controlled, Double-blind, Multi-center Dose Finding Phase II Trial Exploring the Pharmacodynamic Effects, Safety and Tolerability, and Pharmacokinetics of Four Dose Regimens of the Oral sGC Stimulator BAY1021189 Over 12 Weeks in Patients With Worsening Heart Failure and Preserved Ejection Fraction (HFpEF)
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Bayer.