Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Ardea Biosciences, Inc. |
---|---|
Information provided by: | Ardea Biosciences, Inc. |
ClinicalTrials.gov Identifier: | NCT00741442 |
The purpose of this study is to determine whether RDEA806 is effective in the treatment of hyperuricemia in gout patients.
Condition | Intervention | Phase |
---|---|---|
Hyperuricemia |
Drug: RDEA806 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind, Multicenter,Placebo-Controlled, Dose Ranging, Efficacy and Safety Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout |
Estimated Enrollment: | 30 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
RDEA806 400 mg qd
|
Drug: RDEA806
Uricosuric agent for the treatment of gout
|
3: Experimental
RDEA806 400 mg bid
|
Drug: RDEA806
Uricosuric agent for the treatment of gout
|
2: Placebo Comparator
Placebo QD
|
Drug: Placebo
Matching Placebo.
|
4: Placebo Comparator
Placebo BID
|
Drug: Placebo
Matching Placebo.
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Beth Sheedy | 858.652.6604 | bsheedy@ardeabio.com |
Canada, Ontario | |
Recruiting | |
Toronto, Ontario, Canada, M9W 4L6 |
Study Director: | Vijay Hingorani, MD, PhD, MBA | Ardea Biosciences, Inc. |
Responsible Party: | Ardea Biosciences, Inc ( Kimberly J. Manhard ) |
Study ID Numbers: | RDEA806-501 |
Study First Received: | August 25, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00741442 |
Health Authority: | Canada: Health Canada |
Hyperuricemia Gout |
Pathologic Processes |