NCT05573477

Evaluation of Efficacy and Safety of ATB-1011+ATB-1012 Co-administration for Essential Hypertension and Type II Diabetes

A Randomized, Active-controlled, Double-blind, Parallel, Multi Center, Phase 3 Study to Evaluate the Efficacy and Safety of Co-administrated ATB-1011 and ATB-1012 in Patients With Essential Hypertension and Type II Diabetes Mellitus

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: Autotelicbio · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Conditions

• Essential Hypertension
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	ATB-1011	Oral tablet
DRUG	ATB-1012	Oral tablet
DRUG	ATB-1013	Oral tablet
DRUG	ATB-1011 placebo	Placebo matched to ATB-1011
DRUG	ATB-1012 placebo	Placebo matched to ATB-1012
DRUG	ATB-1013 placebo	Placebo matched to ATB-1013

Timeline

• Start date: 2022-11-16
• Primary completion: 2024-01-01
• Completion: 2024-06-01
• First posted: 2022-10-10
• Last updated: 2023-02-01

Locations

1 site across 1 country: South Korea