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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Republic of Korea
The Catholic University of Korea Bucheon St. Mary's Hospital
RECRUITING
Seoul
Contact Information
Primary
Kang
kyliekang@hanlim.com
82234896198
Time Frame
Start Date: 2025-12-18
Estimated Completion Date: 2028-12
Participants
Target number of participants: 228
Treatments
Experimental: Test group
Experimental: Exploratory test group
Placebo_comparator: Control group 1
Placebo_comparator: Control group 2
Related Therapeutic Areas
Sponsors
Leads: Hanlim Pharm. Co., Ltd.