Efficacy and Safety of Telmisartan Compared With Losartan

NCT ID: NCT06431477

Last Updated: 2024-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-19

Study Completion Date

2025-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Nephropathies Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Telmisartan tablet

Group Type EXPERIMENTAL

telmisartan

Intervention Type DRUG

QD, PO

Losartan tablet

Group Type ACTIVE_COMPARATOR

Losartan

Intervention Type DRUG

QD, PO

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

telmisartan

QD, PO

Intervention Type DRUG

Losartan

QD, PO

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

BeomSeok Kim, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

BeomSeok Kim, M.D, Ph.D

Role: CONTACT

+82-2-2228-5331

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

BeomSeok Kim, M.D, Ph.D

Role: primary

+02-2228-5331

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B115_02HT/DN2201

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.