Efficacy and Safety of Telmisartan Compared With Losartan

Chong Kun Dang

Status and phase: Enrolling; Phase 4

Conditions: Hypertension; Diabetic Nephropathies

Treatments: Drug: Losartan; Drug: telmisartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT06431477

B115_02HT/DN2201

Details and patient eligibility

About

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

Full description

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

Enrollment: 98 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Telmisartan tablet

Experimental group

Treatment:

Drug: telmisartan

Losartan tablet

Active Comparator group

Treatment:

Drug: Losartan