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| 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:
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure Renal Insufficiency |
Drug: Tonapofylline 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 Tonapofylline in Patients With Heart Failure and Renal Insufficiency |
| Estimated Enrollment: | 300 |
| 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 |
|---|---|
|
1: Experimental
oral Dose 1
|
Drug: Tonapofylline
Oral Tonapofylline - 2 capsules bid
|
|
2: Experimental
oral Dose 2
|
Drug: Tonapofylline
Oral Tonapofylline - 2 capsules bid
|
|
3: Experimental
oral Dose 3
|
Drug: Tonapofylline
Oral Tonapofylline - 2 capsules bid
|
|
4: Experimental
oral Dose 4
|
Drug: Tonapofylline
Oral Tonapofylline - 2 capsules bid
|
|
5: Experimental
oral Dose 5
|
Drug: Tonapofylline
Oral Tonapofylline - 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 30 Study Locations| 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: | January 19, 2010 |
| ClinicalTrials.gov Identifier: | NCT00745316 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Heart Failure Renal Insufficiency Congestive Heart Failure |
|
Renal Insufficiency Heart Failure Heart Diseases |
Urologic Diseases Cardiovascular Diseases Kidney Diseases |