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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

ConditionsHypertensionDiabete Type 2
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorHanlim Pharm. Co., Ltd.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Test group

    Drug

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

  • Exploratory test group

    Drug

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

  • Control group 1

    Drug

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

  • Control group 2

    Drug

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

Treatment groups

228 Participants
are divided into 4 treatment groups
Group A: Test groupExperimental treatment 1 intervention
Group B: Exploratory test groupExperimental treatment 1 intervention
Group C: Control group 1Placebo comparator 1 intervention
Group D: Control group 2Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

Change from baseline in HbA1c at Week 12, comparing HL1113T2 with HL1113R1 monotherapy (Test group vs Control group 1)

Time frame
Baseline, 12weeks

Secondary outcomes

1

Change from baseline in HbA1c at Week 12, comparing HL1113T2 with HL1113R2 monotherapy (Test group vs Control group 2)

Time frame
Baseline, 12weeks
2

Change from baseline in MSSBP at Week 12, comparing HL1113T2 with HL1113R1 monotherapy (Test group vs Control group 1)

Time frame
Baseline, 12weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hanlim Pharm. Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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