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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

NCT07552389 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2026-04-27

No results posted yet for this study

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

Conditions

Interventions

DRUG

Test group

HL1113T2 + placebo of HL1113T1, HL1113R1, HL1113R2, once daily, administered for 12 weeks

DRUG

Exploratory test group

HL1113T1 + placebo of HL1113T2, HL1113R1, HL1113R2, once daily, administered for 12 weeks

DRUG

Control group 1

HL1113R1 + placebo of HL1113T1, HL1113T2, HL1113R2, once daily, administered for 12 weeks

DRUG

Control group 2

HL1113R2 + placebo of HL1113T1, HL1113T2, HL1113R1, once daily, administered for 12 weeks

Sponsors & Collaborators

  • Hanlim Pharm. Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-18
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07552389 on ClinicalTrials.gov