Diabetic NephropathiesPhase 4NCT06431477
Efficacy and Safety of Telmisartan Compared With Losartan
A Phase 4 study testing telmisartan and Losartan in people with Diabetic Nephropathies and Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A study to evaluate the efficacy and safety of telmisartan compared with losartan in patients with diabetic nephropathy and hypertension Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Diabetic Nephropathies, Hypertension
- What is being tested?
- telmisartan and Losartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Apr 2023to 31 Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul
BeomSeok Kim, M.D, Ph.D, +02-2228-5331, DOCBSK@yuhs.ac
About this study
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
A study to evaluate the efficacy and safety of telmisartan compared with losartan in patients with diabetic nephropathy and hypertension
Read the 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
- Conditions
- Diabetic Nephropathies, Hypertension
- Being tested
- telmisartan, Losartan
- Medical subject headings
- Diabetic Nephropathies, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telmisartanDrug
QD, PO
LosartanDrug
QD, PO
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan tablet | Experimental | Not described Receives: Drug: telmisartan |
| Losartan tablet | Active comparator | Not described Receives: Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change rate from baseline in Spot-UACR(Albumin/Creatinine Ratio)
Measured: 24 weeks after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start19 Apr 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- BeomSeok Kim, M.D, Ph.D, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431477
- Sponsor's protocol ID
- B115_02HT/DN2201
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06431477
- Acronym / sponsor ID
- B115_02HT/DN2201
- Conditions
- Diabetic Nephropathies, Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the efficacy and safety of telmisartan compared with losartan in patients with diabetic nephropathy and hypertension
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan tablet | Experimental | Drug: telmisartan |
| Losartan tablet | Active comparator | Drug: Losartan |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telmisartanQD, PO | Drug | Telmisartan tablet |
| LosartanQD, PO | Drug | Losartan tablet |
Primary outcome
Change rate from baseline in Spot-UACR(Albumin/Creatinine Ratio)
Time frame: 24 weeks after drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Individual participant dataSharing planned: No
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Pentoxifylline in Diabetic Kidney Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BeomSeok Kim, M.D, Ph.D principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing telmisartan and Losartan in people with Diabetic Nephropathies and Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BeomSeok Kim, M.D, Ph.D (+82-2-2228-5331, DOCBSK@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change rate from baseline in Spot-UACR(Albumin/Creatinine Ratio) (time frame: 24 weeks after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.