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
Recruiting · NCT07552389 · Interventional (participants receive a specific treatment) · Lead sponsor: Hanlim Pharm. Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
Control group 1Control group 2Exploratory test groupTest group
What this trial is about
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
Who can take part
Age range
19 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- The Catholic University of Korea Bucheon St. Mary's Hospital - Seoul, South Korea