Diabetic Nephropathies, Hypertension
Conditions
Brief summary
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
Interventions
DRUGtelmisartan
QD, PO
DRUGLosartan
QD, PO
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change rate from baseline in Spot-UACR(Albumin/Creatinine Ratio) | 24 weeks after drug administration |
Countries
South Korea
Contacts
Primary ContactBeomSeok Kim, M.D, Ph.D
Outcome results
None listed