A Phase IIb Study to Investigate the Efficacy and Tolerab... | NCT01064037

Studies
A Phase IIb Study to Investigate the Efficacy and Tolerability of Cinaciguat (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

NCT01064037

Sponsor

Bayer

Status

Terminated

Last Update Posted

Oct 8, 2015Estimated

Enrollment

62Actual

Phase

Phase 2

Conditions

Heart Failure
Heart Decompensation

Interventions

Cinaciguat (BAY58-2667)
Cinaciguat (BAY58-2667)
Cinaciguat (BAY58-2667)
Placebo

Countries

United States
Canada
Czechia
Finland
France
Germany
Hungary
Ireland
Israel
Italy
Japan
Poland
South Africa
South Korea
Spain
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2009-017082-39	EudraCT Number

Official Title

A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY 58-2667 (50 µg/h, 100 µg/h, 150 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF) Within 12 Hours After Hospital Admission (Pulmonary Artery Catheter eg, Swan-Ganz Not Required)

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Feb 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Feb 4, 2010

First Submission Date that Met QC Criteria

Feb 5, 2010

First Posted Date

Feb 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Sep 23, 2015

Certification/Extension First Submitted that Passed QC Review

Sep 23, 2015

Certification/Extension First Posted Date

Oct 8, 2015Estimated

Last Update Submitted Date

Sep 23, 2015

Last Update Posted Date

Oct 8, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Arm 1	Experimental	Drug: Cinaciguat (BAY58-2667)
Arm 2	Experimental	Drug: Cinaciguat (BAY58-2667)
Arm 3	Experimental	Drug: Cinaciguat (BAY58-2667)
Arm 4	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cinaciguat (BAY58-2667)	Drug	Infusion of 150 µg/h during 48h.	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dyspnea VAS (using a visual analogue scale)		8 hours

Secondary Outcomes

Measure	Description	Time Frame
Dyspnea assessment (Likert Scale)		up to follow-up (30 - 35 days)
Overall health status assessment (EQ-5D)		up to follow-up (30 - 35 days)
Changes in the dyspnea VAS at other time points

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and non-pregnant, non-lactating female subjects, age >/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovarectomy, and women with a hysterectomy
Subjects must have the clinical diagnosis of congestive heart failure (CHF) made at least three months prior to enrollment
Subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study: dyspnea and clinical evidence of volume overload

Exclusion Criteria:

Acute de-novo heart failure
Acute myocardial infarction and/or myocardial infarction within 30 days
Valvular heart disease requiring surgical intervention during the course of the study
Heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
Primary hypertrophic cardiomyopathy
Acute inflammatory heart disease, eg, acute myocarditis
Unstable angina requiring angiography

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Chicago	Illinois	60610	United States

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases