NCT05573477CompletedPhase 3
Evaluation of Efficacy and Safety of ATB-1011+ATB-1012 Co-administration for Essential Hypertension and Type II Diabetes
A Randomized, Active-controlled, Double-blind, Parallel, Multi Center, Phase 3 Study to Evaluate the Efficacy and Safety of Co-administrated ATB-1011 and ATB-1012 in Patients With Essential Hypertension and Type II Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 255 (actual)
- First submitted
- 5 Oct 2022
- Start date
- 16 Nov 2022
- Primary completion date
- 31 Aug 2025
- Lead sponsor
- Autotelicbio
- Diseases
- High blood pressure, Type 2 diabetes
- NCT number
- NCT05573477
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 255
- From 16 Nov 2022 to the primary completion date, 31 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those who have received other clinical trial drugs within 12 weeks prior to screening
Other illness
- Those with a history of alcohol or substance abuse
Other
- 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 who are pregnant or nursing
- Those who are deemed ineligible to participate in the clinical trial based on the medical opinion of the investigator
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.