HL1113R1 and HL1113R2 monotherapy versus HL1113 fixed‑dose combination for people with high blood pressure and type 2 diabetes
A Randomized, Active Controlled, Double Blind, Parallel, Multi Center, Phase 3 Study to Evaluate the Efficacy and Safety of Monotherapy Group of HL1113R1 or HL1113R2 Versus HL1113 (Fixed Dose Combination) in Patients With Essential Hypertension and Type II Diabetes Mellitus
This trial will test whether taking HL1113R1 or HL1113R2 alone works as well and is as safe as the HL1113 fixed‑dose combination in adults with essential hypertension and type 2 diabetes.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 228 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Hanlim Pharm. Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07552389 on ClinicalTrials.gov |
What this trial studies
This randomized, double‑blind, active‑controlled, parallel-group phase 3 trial compares two monotherapy regimens (HL1113R1 and HL1113R2) to a fixed‑dose combination (HL1113) in adults with essential hypertension and type 2 diabetes. Participants are randomized to one of the test, exploratory test, or control groups and receive blinded study medication with regular blood pressure and safety monitoring. Primary efficacy endpoints will focus on blood pressure control and secondary endpoints will include safety and tolerability measures as defined in the protocol. The multicenter study is sponsored by Hanlim Pharm. Co., Ltd., with at least one participating site at The Catholic University of Korea Bucheon St. Mary's Hospital.
Who should consider this trial
Good fit: Adults aged 19 or older with diagnosed essential hypertension accompanied by type 2 diabetes who meet the trial's blood pressure and health criteria are the intended participants.
Not a fit: People with very high screening blood pressure (for example MSDBP ≥ 110 mmHg) or who meet the study's exclusion criteria may not receive benefit from participation.
Why it matters
Potential benefit: If successful, the results could offer patients a simpler or safer medication option that controls blood pressure as well as the fixed‑dose combination.
How similar studies have performed: Fixed‑dose antihypertensive combinations have frequently improved blood pressure control in prior studies, but head‑to‑head data for these specific HL1113 monotherapy variants versus the HL1113 combination are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult male or female subjects aged ≥19 years at the time of written informed consent. * Subjects diagnosed with essential hypertension accompanied by type 2 diabetes mellitus. * etc. Exclusion Criteria: * Subjects whose blood pressure measured in the selected arm at both screening and randomization meets the following criterion: MSDBP ≥ 110 mmHg * Subjects whose blood pressure measured three consecutive times in each arm at intervals of at least 2 minutes at screening shows a difference of ≥20 mmHg in SBP and ≥10 mmHg in DBP. * etc.
Where this trial is running
Seoul
- The Catholic University of Korea Bucheon St. Mary's Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Kang
- Email: kyliekang@hanlim.com
- Phone: 82234896198
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.