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Recruiting NCT07552389

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

Phase III Interventional Hypertension Diabete Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Test group, Exploratory test group, Control group 1, Control group 2.
Who it may be relevant to
Registry conditions: Hypertension, Diabete Type 2. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • Change from baseline in mean seated systolic blood pressure (MSSBP) at Week 12, comparing HL1113T2 with HL1113R2 monotherapy (Test group vs Control group 2) [Time frame: Baseline, 12weeks]
  • Change from baseline in HbA1c at Week 12, comparing HL1113T2 with HL1113R1 monotherapy (Test group vs Control group 1) [Time frame: Baseline, 12weeks]
Secondary outcome measures (2)
  • Change from baseline in HbA1c at Week 12, comparing HL1113T2 with HL1113R2 monotherapy (Test group vs Control group 2) [Time frame: Baseline, 12weeks]
  • Change from baseline in MSSBP at Week 12, comparing HL1113T2 with HL1113R1 monotherapy (Test group vs Control group 1) [Time frame: Baseline, 12weeks]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • The Catholic University of Korea Bucheon St. Mary's Hospital — Seoul

Identifiers

NCT: NCT07552389 · HL1113-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗