Evaluation of Efficacy and Safety of ATB-1011+ATB-1012 Co-administration for Essential Hypertension and Type II Diabetes
Evaluation of Efficacy and Safety of ATB-1011+ATB-1012 Co-administration for Essential Hypertension and Type II Diabetes
ClinicalTrials.gov ID: NCT05573477
Sponsor: Autotelicbio
Information provided by: Autotelicbio (Responsible Party)
Last Update Posted: 2023-02-01
Brief Summary:
The purpose of this study is to evaluate safety and efficacy of ATB-1011 and ATB-1012 co-administration in patients with essential hypertension and type II diabetes mellitus
Detailed Description:
Primary Objectives:
- To demonstrate superiority of 12-week co-administration of ATB-1011 and ATB-1012 in blood pressure control over ATB-1012 monotherapy
- To demonstrate superiority of 12-week co-administration of ATB-1011 and ATB-1012 in diabetes control over ATB-1011 monotherapy
Intervention / Treatment:
- Drug: ATB-1011
- Drug: ATB-1012
- Drug: ATB-1013
- Drug: ATB-1011 placebo
- Drug: ATB-1012 placebo
- Drug: ATB-1013 placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2022-11-16 |
| Primary Completion (Estimated) | 2024-01 |
| Study Completion (Estimated) | 2024-06 |
| Enrollment (Estimated) | 248 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
ATB-101-003 |