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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00621868 |
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP1941 in male and female patients with type 2 diabetes mellitus
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus |
Drug: ASP1941 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus |
Estimated Enrollment: | 310 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Lowest dose
|
Drug: ASP1941
Oral
|
2: Experimental
Low-middle dose
|
Drug: ASP1941
Oral
|
3: Experimental
High-middle dose
|
Drug: ASP1941
Oral
|
4: Experimental
Highest dose
|
Drug: ASP1941
Oral
|
5: Placebo Comparator |
Drug: Placebo
Oral
|
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Clinical Development Administration Dep. Astellas Pharma Inc. | clinicaltrials_info@jp.astellas.com |
Japan | |
Recruiting | |
Hokkaidou, Japan | |
Recruiting | |
Touhoku, Japan | |
Recruiting | |
Kantou, Japan | |
Recruiting | |
Chubu, Japan | |
Recruiting | |
Kyushu, Japan | |
Recruiting | |
Chugoku, Japan | |
Recruiting | |
Shikoku, Japan | |
Recruiting | |
Kansai, Japan |
Study Chair: | Central Contact | Astellas Pharma Inc |
Responsible Party: | Astellas Pharma Inc. ( Director ) |
Study ID Numbers: | 1941-CL-0103 |
Study First Received: | February 13, 2008 |
Last Updated: | July 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00621868 |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Diabetes Mellitus, Type 2 ASP1941 |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |