MedTrace Logo

A Randomized, Double-blind, Multi-center, Active-controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of THP-00101, THP-00102, and THP-00103 in Subjects With T2DM and Essential Hypertension

NCT06647745 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2025-09-12

No results posted yet for this study

Summary

\[Primary Objective\] To demonstrate the superiority of the change in mean sitting systolic blood pressure (MSSBP) and hemoglobin A1c (HbA1c)on week 12 of the combination therapy of THP-00101 (dapagliflozin 10 mg) and THP-00102 (telmisartan 80 mg) compared to THP-00101 or THP-00102 monotherapy among subjects with type 2 diabetes mellitus accompanied by essential hypertension. \[Secondary Objective\] To comparatively evaluate secondary efficacy and safety in the THP-00101 monotherapy group, THP-00102 monotherapy group, THP-00101 and THP-00102 combination therapy group, and THP-00101 and THP-00103 (telmisartan 40 mg) combination therapy group among subjects with type 2 diabetes mellitus accompanied by essential hypertension.

Conditions

Interventions

DRUG

THP-00101

Dapagliflozin 10 mg

DRUG

THP-00102

Telmisartan 80 mg

DRUG

THP-00103

Telmisartan 40 mg

DRUG

THP-00104

Placebo of Dapagliflozin 10mg

DRUG

THP-00105

Placebo of Telmisartan 80mg

DRUG

THP-00106

Placebo of Telmisartan 40mg

Sponsors & Collaborators

  • THPharm Corp.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-10
Primary Completion
2026-06-01
Completion
2026-12-01

Countries

  • South Korea
  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06647745 on ClinicalTrials.gov