Clinical Trial Details
| Trial ID: | L1548 |
| Source ID: | NCT01955694 |
| Associated Drug: | Bay94-8862 |
| Title: | Phase IIb Safety and Efficacy Study of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Moderate Chronic Kidney Disease Alone |
| Acronym: | ARTS-HF Japan |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Heart Failure |
| Interventions: | DRUG: BAY94-8862|DRUG: Eplerenone|DRUG: Placebo |
| Outcome Measures: | Primary: The percentage of subjects with a relative decrease in N-terminal prohormone B-type natriuretic peptide of more than 30% from baseline to Visit 10, From baseline to 90 days | Secondary: Change in serum potassium, From baseline to 90 days |
| Sponsor/Collaborators: | Sponsor: Bayer |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 72 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2013-11-11 |
| Completion Date: | 2015-02-20 |
| Results First Posted: | |
| Last Update Posted: | 2021-07-16 |
| Locations: | Seto, Aichi, 489-8642, Japan|Toyota, Aichi, 471-8513, Japan|Funabashi, Chiba, 273-8588, Japan|Kamogawa, Chiba, 296-8602, Japan|Matsuyama, Ehime, 790-0067, Japan|Chikushino, Fukuoka, 818-8516, Japan|Amagasaki, Hyogo, 660-8550, Japan|Kobe, Hyogo, 650-0047, Japan|Kobe, Hyogo, 654-0155, Japan|Higashiibaraki, Ibaraki, 311-3193, Japan|Hiratsuka, Kanagawa, 254-8502, Japan|Kawasaki, Kanagawa, 211-8533, Japan|Yokohama, Kanagawa, 245-8575, Japan|Uji, Kyoto, 611-0041, Japan|Sendai, Miyagi, 983-8520, Japan|Naha, Okinawa, 900-0005, Japan|Naha, Okinawa, 902-8511, Japan|Urasoe, Okinawa, 901-2132, Japan|Sayama, Saitama, 350-1305, Japan|Kusatsu, Shiga, 525-8585, Japan|Shinjuku-ku, Tokyo, 162-8655, Japan|Shinjuku-ku, Tokyo, 162-8666, Japan|Kofu, Yamanashi, 400-8506, Japan|Fukuoka, 810-0001, Japan|Kagoshima, 892-0853, Japan|Kyoto, 607-8062, Japan|Okayama, 700-8607, Japan|Osaka, 558-8558, Japan|Shizuoka, 420-8630, Japan |
| URL: | https://clinicaltrials.gov/show/NCT01955694 |
