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