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

Last updated: January 31, 2023
Sponsor: Autotelicbio
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes Mellitus, Type 2

Stress

High Blood Pressure (Hypertension - Pediatric)

Treatment

N/A

Clinical Study ID

NCT05573477
ATB-101-003
  • Ages > 19
  • All Genders

Study 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

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 ofthe clinical trial and have given voluntary, written informed consent
  • Those who have not taken any antihypertensive agents for ≥2 weeks prior torandomization.
  • Those who have not taken any oral hypoglycemic agents, except for same dose ofmetformin (≥1000 mg/day), for ≥8 weeks prior to randomization

Exclusion

Exclusion Criteria:

  • Those with reference arm mean sitting diastolic blood pressure (MSDBP) ≥110 mmHg atscreening or at randomization
  • Those with differences of systolic blood pressure (SBP) ≥ 20 mmHg and diastolic bloodpressure (DBP) ≥ 10 mmHg between arms measured 3 consecutive times with ≥2 minutesbetween 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 themedical opinion of the investigator

Study Design

Total Participants: 248
Study Start date:
November 16, 2022
Estimated Completion Date:
June 30, 2024

Study 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

Connect with a study center

  • Seoul National University Bundang Hospital

    Seongnam, Gyeonggi 13620
    Korea, Republic of

    Active - Recruiting

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