Oral BG9928 in Patients With Heart Failure and Renal Insufficiency - Full Text View

Sponsor:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00745316

Purpose

The main purpose of this study is to determine the safety and tolerability of BG9928 when given at different doses to patients with heart failure and renal insufficiency.

This study will also explore:

Disease related quality-of-life
Exercise capacity
Renal function
Concomitant medications

Condition	Intervention	Phase
Heart Failure Renal Insufficiency	Drug: Tonapofylline Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral Tonapofylline in Patients With Heart Failure and Renal Insufficiency

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Adenosine

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

To assess the safety and tolerability of BG9928 administered to subjects with heart failure and renal insufficiency. [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]

Enrollment:	34
Study Start Date:	February 2009
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 oral Dose 1	Drug: Tonapofylline Oral Tonapofylline - 2 capsules bid Other Name: Selective Adenosine A1 Receptor Antagonist
Experimental: 2 oral Dose 2	Drug: Tonapofylline Oral Tonapofylline - 2 capsules bid Other Name: Selective Adenosine A1 Receptor Antagonist
Experimental: 3 oral Dose 3	Drug: Tonapofylline Oral Tonapofylline - 2 capsules bid Other Name: Selective Adenosine A1 Receptor Antagonist
Experimental: 4 oral Dose 4	Drug: Tonapofylline Oral Tonapofylline - 2 capsules bid Other Name: Selective Adenosine A1 Receptor Antagonist
Experimental: 5 oral Dose 5	Drug: Tonapofylline Oral Tonapofylline - 2 capsules bid Other Name: Selective Adenosine A1 Receptor Antagonist
Placebo Comparator: 6 Placebo - 2 capsules bid	Drug: Placebo Oral placebo - 2 capsules bid

Eligibility

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

Criteria

Inclusion Criteria:

18 years of age or older
Diagnosis of heart failure requiring hospitalization >1 and ≤12 months prior to screening
NYHA Class III or IV at the time of screening
Renal insufficiency as defined by eGFR ≥20 and ≤70 mL/min/1.73 m2
Negative pregnancy test

Exclusion Criteria:

History of an allergic reaction to any xanthine-containing compound.
History of seizure
History of stroke
Serious systemic infection
Sustained systolic blood pressure >170 or <90 mmHg
Myocardial infarction within 30 days of Day 1
Hemodynamically destabilizing arrhythmia within 30 days of Day 1
Uncorrected hemodynamically significant primary valvular disease
Known obstructive or restrictive cardiomyopathy
Cardiac surgery within 60 days prior to Day 1
Likely to undergo cardiac transplantation, device implantation, or other cardiac surgery within next three months
Evidence of malignancy within 6 months prior to Day 1.
Participation in any other investigational study of drugs or devices within 30 days prior to Day 1.
Receiving aminophylline, theophylline, pentoxifylline, dyphylline or adenosine
Presence of any clinically significant condition that might interfere with optimal safe participation in this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745316

Show 30 Study Locations

Sponsors and Collaborators

Biogen Idec

Investigators

Study Director:

Biogen Idec Medical Director

Biogen Idec, Cambridge, MA USA

More Information

No publications provided

Responsible Party:	Biogen Idec, Medical Director, Biogen Idec
ClinicalTrials.gov Identifier:	NCT00745316 History of Changes
Other Study ID Numbers:	161HF201
Study First Received:	September 2, 2008
Last Updated:	March 4, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen Idec:

Heart Failure
Renal Insufficiency
Congestive Heart Failure

Additional relevant MeSH terms:

Heart Failure
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Adenosine A1 Receptor Antagonists

Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012