Evaluation of Efficacy and Safety of ATB-1011+ATB-1012 Co-administration for Essential Hypertension and Type II Diabetes
NCT ID: NCT05573477
Last Updated: 2023-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
248 participants
INTERVENTIONAL
2022-11-16
2024-06-30
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ATB-1011 + ATB-1012
Participants will receive 1 tablet/day of each drug for 12 weeks
ATB-1011
Oral tablet
ATB-1012
Oral tablet
ATB-1013 placebo
Placebo matched to ATB-1013
ATB-1012 + ATB-1013
Participants will receive 1 tablet/day of each drug for 12 weeks
ATB-1012
Oral tablet
ATB-1013
Oral tablet
ATB-1011 placebo
Placebo matched to ATB-1011
ATB-1011
Participants will receive 1 tablet/day of each drug for 12 weeks
ATB-1011
Oral tablet
ATB-1012 placebo
Placebo matched to ATB-1012
ATB-1013 placebo
Placebo matched to ATB-1013
ATB-1012
Participants will receive 1 tablet/day of each drug for 12 weeks
ATB-1012
Oral tablet
ATB-1011 placebo
Placebo matched to ATB-1011
ATB-1013 placebo
Placebo matched to ATB-1013
Interventions
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ATB-1011
Oral tablet
ATB-1012
Oral tablet
ATB-1013
Oral tablet
ATB-1011 placebo
Placebo matched to ATB-1011
ATB-1012 placebo
Placebo matched to ATB-1012
ATB-1013 placebo
Placebo matched to ATB-1013
Eligibility Criteria
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Inclusion Criteria
* 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 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
19 Years
ALL
No
Sponsors
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Autotelicbio
INDUSTRY
Responsible Party
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Principal Investigators
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James Jun, MD
Role: STUDY_DIRECTOR
Autotelicbio
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Dong-Ju Choi, MD, PhD
Role: primary
Other Identifiers
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ATB-101-003
Identifier Type: -
Identifier Source: org_study_id
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