Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure and Preserved Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-PRESERVED)

ClinicalTrials.gov ID: NCT01951638

Public ClinicalTrials.gov record NCT01951638. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 27, 2026, 1:38 PM EDT

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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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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)

Study identification

NCT ID: NCT01951638
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Bayer; Industry
Enrollment: 477 participants

Conditions and interventions

Conditions

Heart Failure

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 6, 2013 (Actual)
Primary completion: Aug 18, 2015 (Actual)
Completion: Sep 16, 2015 (Actual)
Last update posted: Mar 16, 2021

2013 – 2015

United States locations

U.S. sites: 17
U.S. states: 15
U.S. cities: 17

Facility	City	State	ZIP	Site status
Not listed	Fountain Valley	California	92708	—
Not listed	Fort Lauderdale	Florida	33308	—
Not listed	Naples	Florida	34102	—
Not listed	Macon	Georgia	31201	—
Not listed	Chicago	Illinois	60611-2908	—
Not listed	Iowa City	Iowa	52242	—
Not listed	New Orleans	Louisiana	70112-1396	—
Not listed	Detroit	Michigan	48202	—
Not listed	Minneapolis	Minnesota	55422	—
Not listed	Jackson	Mississippi	39216-4505	—
Not listed	Newark	New Jersey	07103	—
Not listed	Buffalo	New York	14215	—
Not listed	Pittsburgh	Pennsylvania	15212	—
Not listed	Charleston	South Carolina	29425	—
Not listed	Germantown	Tennessee	38138	—
Not listed	Nashville	Tennessee	37232-8802	—
Not listed	Milwaukee	Wisconsin	53215	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 141 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01951638, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 16, 2021 · Synced Oct 27, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01951638 live on ClinicalTrials.gov.

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