Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Completed NCT05573477

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

Conditions: Essential Hypertension, Diabetes Mellitus, Type 2

Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 255
Sponsor: Autotelicbio

Location: Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do

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

Eligibility 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05573477). StuddyBuddy aggregates publicly available trial information.