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Clinical Trial Details

Trial ID: L7134
Source ID: NCT05573477
Associated Drug: Atb-1011
Title: Evaluation of Efficacy and Safety of ATB-1011+ATB-1012 Co-administration for Essential Hypertension and Type II Diabetes
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Essential Hypertension|Diabetes Mellitus, Type 2
Interventions: DRUG: ATB-1011|DRUG: ATB-1012|DRUG: ATB-1013|DRUG: ATB-1011 placebo|DRUG: ATB-1012 placebo|DRUG: ATB-1013 placebo
Outcome Measures: Primary: Mean sitting systolic blood pressure (MSSBP) (ATB-1011+ATB-1012 vs. ATB-1012), Change in MSSBP with ATB-1011 + ATB-1012 co-administration compared to ATB-1012 monotherapy, baseline to Week 12|Hemoglobin A1c (HbA1c) (ATB-1011+ATB-1012 vs. ATB-1011), Changes in HbA1c with ATB-1011 + ATB-1012 co-administration compared to ATB-1011 monotherapy, baseline to Week 12 | Secondary: MSSBP (ATB-1011+ATB-1012 vs. ATB-1011), Changes in MSSBP with ATB-1011 + ATB-1012 co-administration compared to ATB-1011 monotherapy, baseline to Week 12|MSSBP (ATB-1012+ATB-1013 vs. ATB-1012), Changes in MSSBP with ATB-1012 + ATB-1013 co-administration compared to ATB-1012 monotherapy, baseline to Week 12|MSSBP (ATB-1012+ATB-1013 vs ATB-1011+ATB-1012), Changes in MSSBP with ATB-1012 + ATB-1013 co-administration compared to ATB-1011 + ATB-1012 co-administration, baseline to Week 12|HbA1c (ATB-1011+ATB-1012 vs. ATB-1012), Changes in HbA1c with ATB-1011 + ATB-1012 co-administration compared to ATB-1012 monotherapy, baseline to Week 12|Changes in MSSBP, baseline to Weeks 4 and 8|Changes in mean sitting diastolic blood pressure (MSDBP), baseline to Weeks 4, 8, and 12|Changes in HbA1c, baseline to Weeks 4, 8, and 12|Changes in glycemic parameters, Fasting plasma glucose (FPG), baseline to Weeks 4, 8, and 12|Changes in glycemic parameters, Homeostatic model assessment of beta cell function (HOMA-beta), baseline to Weeks 4, 8, and 12|Changes in glycemic parameters, Homeostatic model assessment of insulin resistance (HOMA-IR), baseline to Weeks 4, 8, and 12 | Other: Extension period: Changes in HbA1c, baseline and Week 12 to Weeks 18 and 24|Extension period: Changes in MSSBP, baseline and Week 12 to Weeks 18 and 24|Extension period: Changes in MSDBP, baseline and Week 12 to Weeks 18 and 24
Sponsor/Collaborators: Sponsor: Autotelicbio
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 248
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-11-16
Completion Date: 2024-06
Results First Posted:
Last Update Posted: 2023-02-01
Locations: Seoul National University Bundang Hospital, Seongnam, Gyeonggi, 13620, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT05573477