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NCT06431477 Clinical Trial

Efficacy and Safety of Telmisartan Compared With Losartan

Hypertension Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06431477
Other study ID # B115_02HT/DN2201
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date April 19, 2023
Est. completion date October 31, 2025

Study information
Verified date May 2024
Source Chong Kun Dang Pharmaceutical
Contact BeomSeok Kim, M.D, Ph.D
Phone +82-2-2228-5331
Email DOCBSK@yuhs.ac
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 98
Est. completion date October 31, 2025
Est. primary completion date October 31, 2025
Accepts healthy volunteers No
Gender All
Age group 19 Years to 75 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• telmisartan
QD, PO
• Losartan
QD, PO

Locations
Country Name City State
Korea, Republic of Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change rate from baseline in Spot-UACR(Albumin/Creatinine Ratio) 24 weeks after drug administration
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