Efficacy and Safety of Telmisartan Compared With Losartan
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
1 other identifier
interventional
98
1 country
1
Brief Summary
A study to evaluate the efficacy and safety of telmisartan compared with losartan in patients with diabetic nephropathy and hypertension
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2023
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 19, 2023
CompletedFirst Submitted
Initial submission to the registry
May 22, 2024
CompletedFirst Posted
Study publicly available on registry
May 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2025
CompletedMay 28, 2024
May 1, 2024
2.5 years
May 22, 2024
May 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change rate from baseline in Spot-UACR(Albumin/Creatinine Ratio)
24 weeks after drug administration
Study Arms (2)
Telmisartan tablet
EXPERIMENTALLosartan tablet
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
BeomSeok Kim, M.D, Ph.D
Severance Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2024
First Posted
May 28, 2024
Study Start
April 19, 2023
Primary Completion
October 31, 2025
Study Completion
October 31, 2025
Last Updated
May 28, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share