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

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

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

Treatments tested in this trial

  • Test group
  • Exploratory test group
  • Control group 1
  • Control group 2

Treatment groups

228 Participants
are divided into 4 treatment groups

Sponsors and collaborators