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Sponsored by: |
Biogen Idec |
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Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00745316 |
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:
Condition | Intervention | Phase |
---|---|---|
Heart Failure Renal Insufficiency |
Drug: BG9928 Drug: Placebo |
Phase II |
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 |
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
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Drug: BG9928
Oral BG9928 - 2 capsules bid
|
2: Experimental
oral Dose 2
|
Drug: BG9928
Oral BG9928 - 2 capsules bid
|
3: Experimental
oral Dose 3
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Drug: BG9928
Oral BG9928 - 2 capsules bid
|
4: Experimental
oral Dose 4
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Drug: BG9928
Oral BG9928 - 2 capsules bid
|
5: Experimental
oral Dose 5
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Drug: BG9928
Oral BG9928 - 2 capsules bid
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6: Placebo Comparator
Placebo - 2 capsules bid
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Drug: Placebo
Oral placebo - 2 capsules bid
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Biogen Idec, Inc Medical Director | immunologyclinicaltrials@biogenidec.com |
Study Director: | Biogen Idec Medical Director | Biogen Idec, Cambridge, MA USA |
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 |
Heart Failure Renal Insufficiency Congestive Heart Failure |
Heart Failure Renal Insufficiency Heart Diseases |
Urologic Diseases Kidney Diseases Adenosine |
Cardiovascular Diseases |