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Oral BG9928 in Patients With Heart Failure and Renal Insufficiency (POSEIDON)
This study is not yet open for participant recruitment.
Verified by Biogen Idec, September 2008
Sponsored by: 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: BG9928
Drug: Placebo
Phase II

MedlinePlus related topics: Heart Failure
Drug Information available for: Adenosine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral BG9928 in Patients With Heart Failure and Renal Insufficiency

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 ]

Estimated Enrollment: 300
Study Start Date: December 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
oral Dose 1
Drug: BG9928
Oral BG9928 - 2 capsules bid
2: Experimental
oral Dose 2
Drug: BG9928
Oral BG9928 - 2 capsules bid
3: Experimental
oral Dose 3
Drug: BG9928
Oral BG9928 - 2 capsules bid
4: Experimental
oral Dose 4
Drug: BG9928
Oral BG9928 - 2 capsules bid
5: Experimental
oral Dose 5
Drug: BG9928
Oral BG9928 - 2 capsules bid
6: Placebo Comparator
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 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

Contacts
Contact: Biogen Idec, Inc Medical Director immunologyclinicaltrials@biogenidec.com

Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Biogen Idec Medical Director Biogen Idec, Cambridge, MA USA
  More Information

Responsible Party: Biogen Idec ( Biogen Idec, Medical Director )
Study ID Numbers: 161HF201
Study First Received: September 2, 2008
Last Updated: September 5, 2008
ClinicalTrials.gov Identifier: NCT00745316  
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
Heart Failure
Renal Insufficiency
Congestive Heart Failure

Study placed in the following topic categories:
Heart Failure
Renal Insufficiency
Heart Diseases
Urologic Diseases
Kidney Diseases
Adenosine

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009