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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Autotelicbio

Criteria

Inclusion Criteria:

• Those with Primary Hypertension and Type II Diabetes Mellitus (DM)

• Those who have been given adequate explanation about the purpose and the details of the clinical trial and have given voluntary, written informed consent

• Those who have not taken any antihypertensive agents for ≥2 weeks prior to randomization.

• Those who have not taken any oral hypoglycemic agents, except for same dose of metformin (≥1000 mg/day), for ≥8 weeks prior to randomization

Exclusion Criteria:

• Those with reference arm mean sitting diastolic blood pressure (MSDBP) ≥110 mmHg at screening or at randomization

• Those with differences of systolic blood pressure (SBP) ≥ 20 mmHg and diastolic blood pressure (DBP) ≥ 10 mmHg between arms measured 3 consecutive times with ≥2 minutes between each measurement at screening

• Those with a history of alcohol or substance abuse

• Those who are pregnant or nursing

• Those who have received other clinical trial drugs within 12 weeks prior to screening

• Those who are deemed ineligible to participate in the clinical trial based on the medical opinion of the investigator