---
title: 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
nct_id: NCT07552389
overall_status: RECRUITING
phase: PHASE3
sponsor: Hanlim Pharm. Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Hypertension
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07552389.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07552389"
ct_last_update_post_date: 2026-04-27
last_seen_at: "2026-05-12T06:50:31.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**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

**NCT ID:** [NCT07552389](https://clinicaltrials.gov/study/NCT07552389)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 228
- **Lead Sponsor:** Hanlim Pharm. Co., Ltd.
- **Conditions:** Hypertension, Diabete Type 2
- **Start Date:** 2025-12-18
- **Completion Date:** 2028-12
- **CT.gov Last Update:** 2026-04-27

## Brief 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

- **Minimum age:** 19 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Test group** (EXPERIMENTAL)
- **Exploratory test group** (EXPERIMENTAL)
- **Control group 1** (PLACEBO_COMPARATOR)
- **Control group 2** (PLACEBO_COMPARATOR)

## Interventions

- **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

## Primary Outcomes

- **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 Outcomes

- **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)_

## Locations (1)

- The Catholic University of Korea Bucheon St. Mary's Hospital, Seoul, South Korea — _RECRUITING_

## Recent Field Changes (last 30 days)

- `outcomes.secondary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the catholic university of korea bucheon st. mary's hospital|seoul||south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07552389.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07552389*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*