Clinical Trial Details
| Trial ID: | L3684 |
| Source ID: | NCT01968668 |
| Associated Drug: | Bay94-8862 |
| Title: | Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy (ARTS-DN Japan) |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetic Nephropathies |
| Interventions: | DRUG: BAY94-8862|DRUG: BAY94-8862|DRUG: BAY94-8862|DRUG: BAY94-8862|DRUG: BAY94-8862|DRUG: Placebo|DRUG: BAY 94-8862|DRUG: BAY 94-8862 |
| Outcome Measures: | Primary: Change of urinary albumin-to creatinine ratio, Baseline and 90 days | Secondary: Change in serum potassium concentration, Baseline and 90 days |
| Sponsor/Collaborators: | Sponsor: Bayer |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 96 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2013-10-28 |
| Completion Date: | 2014-11-07 |
| Results First Posted: | |
| Last Update Posted: | 2021-07-16 |
| Locations: | Nagoya, Aichi, 456-0058, Japan|Nagoya, Aichi, 466-0815, Japan|Saijo, Ehime, 793-0027, Japan|Kurume, Fukuoka, 830-8522, Japan|Kurume, Fukuoka, 830-8543, Japan|Obihiro, Hokkaido, 080-0848, Japan|Amagasaki, Hyogo, 660-8550, Japan|Koga, Ibaraki, 306-0232, Japan|Tsuchiura, Ibaraki, 300-0835, Japan|Tsukuba, Ibaraki, 305-0812, Japan|Kahoku-gun, Ishikawa, 920-0293, Japan|Sakaide, Kagawa, 762-0007, Japan|Izumisano, Osaka, 598-8577, Japan|Yao, Osaka, 581-0011, Japan|Katsushika, Tokyo, 125-0054, Japan|Osaka, 530-0001, Japan |
| URL: | https://clinicaltrials.gov/show/NCT01968668 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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