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Clinical Trial 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

RECRUITINGPhase 3Sponsored by Hanlim Pharm. Co., Ltd.
Actively Recruiting
PhasePhase 3
SponsorHanlim Pharm. Co., Ltd.
Started2025-12-18
Est. completion2028-12
Eligibility
Age19 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07552389

Summary

This clinical trial is 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

Eligibility

Age: 19 Years+Healthy volunteers accepted
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.

Conditions3

Diabete Type 2DiabetesHypertension

Interventions4

Control group 1Control group 2Exploratory test groupTest group

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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