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) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Heart Failure Heart Decompensation	Drug: Cinaciguat (BAY58-2667) Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Breathing Problems Heart Failure

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Dyspnea VAS (using a visual analogue scale) [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Dyspnea assessment (Likert Scale) [ Time Frame: up to follow-up (30 - 35 days) ] [ Designated as safety issue: No ]
Overall health status assessment (EQ-5D) [ Time Frame: up to follow-up (30 - 35 days) ] [ Designated as safety issue: No ]
Changes in the dyspnea VAS at other time points [ Time Frame: Up to follow up visit ] [ Designated as safety issue: No ]
Dyspnea assessment through Likert scale [ Time Frame: Up to follow up visit ] [ Designated as safety issue: No ]
Overall health status assessment through EQ-5D Health Questionnaire [ Time Frame: Up to the follow-up visit ] [ Designated as safety issue: No ]
Global clinical assessment by the physician [ Time Frame: At 8, 24, and 48 hours ] [ Designated as safety issue: No ]
Change in concomitant medications [ Time Frame: During the treatment ] [ Designated as safety issue: No ]
Safety variables [ Time Frame: Up to end of study ] [ Designated as safety issue: Yes ]
Frequency of TEAEs (AEs were considered to be treatment emergent if they started after the start of sthe study drug infusion to up to 2 calendar days after the end of the study drug infusion); treatment-emergent serious adverse events (SAEs); deaths; evaluation of renal and cardiac function; Change in heart rate; Change in systolic and diastolic blood pressure; Laboratory parameters (including parameters related to hematology, clinical chemistry, urinalysis, and biomarkers); ECG assessment

Enrollment:	62
Study Start Date:	April 2010
Study Completion Date:	March 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Cinaciguat (BAY58-2667) Infusion of 150 µg/h during 48h.
Experimental: Arm 2	Drug: Cinaciguat (BAY58-2667) Infusion of 100 µg/h during 48h
Experimental: Arm 3	Drug: Cinaciguat (BAY58-2667) Infusion of 50 µg/h during 48h
Placebo Comparator: Arm 4	Drug: Placebo Infusion during 48h

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064037

Show 70 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer HealthCare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT01064037 History of Changes
Other Study ID Numbers:	14836, 2009-017082-39
Study First Received:	February 4, 2010
Last Updated:	May 13, 2013
Health Authority:	Finland: Finnish Medicines Agency Canada: Health Canada France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: German Institute of Medical Documentation and Information Israel: Ministry of Health Italy: The Italian Medicines Agency Japan: National Institute of Health Sciences Korea: Food and Drug Administration Hungary: National Institute of Pharmacy United Kingdom: Medicines and Healthcare Products Regulatory Agency Spain: Spanish Agency of Medicines South Africa: Human Research Ethics Committee Poland: Ministry of Health Czech Republic: State Institute for Drug Control Ireland: Irish Medicines Board United States: Food and Drug Administration

Keywords provided by Bayer:

Heart Failure

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013

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) (COMPOSE EARLY)