Efficacy and Safety of Telmisartan Compared With Losartan

May 22, 2024 updated by: Chong Kun Dang Pharmaceutical

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

98

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BeomSeok Kim, M.D, Ph.D
  • Phone Number: +82-2-2228-5331
  • Email: DOCBSK@yuhs.ac

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telmisartan tablet
Drug: telmisartan
QD, PO
Active Comparator: Losartan tablet
Drug: Losartan
QD, PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change rate from baseline in Spot-UACR(Albumin/Creatinine Ratio)
Time Frame: 24 weeks after drug administration
24 weeks after drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

  • Principal Investigator: BeomSeok Kim, M.D, Ph.D, Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2023

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2024

Last Update Submitted That Met QC Criteria

May 22, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B115_02HT/DN2201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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