HL1113R1 and HL1113R2 monotherapy versus HL1113 fixed‑dose combination for people with high blood pressure and type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.