A Multi-center, Randomized, Open-label, Active Comparator-controlled, Phase 4 Clinical Trial To Evaluate the Efficacy and Safety of Telmisartan Compared With Losartan in Patients With Diabetic Nephropathy and Hypertension

B115_02HT/DN2201

A study to evaluate the efficacy and safety of telmisartan compared with losartan in patients with diabetic nephropathy and hypertension

2023-04-19

2025-10-31

2025-10-31

Recruiting

Early phase I

98

Inclusion Criteria: * Male of Female subjects aged ≥19 or \<75 * Type II Diabetes Mellitus subjects who have been taken medicine * Subjects who have voluntarily decided to participate in this clinical trial and Signed ICF Exclusion Criteria: * Subjects with Type I Diabetes Mellitus * Subjects with Primary hyper-aldosteronism * Subjects with a history of drug or alcohol abuse or suspected patient within 1 year as of the time of screening * Pregnant women, lactating women, or subjects who do not agree to use appropriate contraception during the clinical trial period * Subjects who received other clinical trial drugs within 28 days of screening visit * Subjects who are unable to participate in this clinical trial at the discretion of the investigator.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 98, 'type': 'ESTIMATED'}}

2024-05-28