Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
AstraZeneca |
---|---|
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00573430 |
To determine the effective dose of candesartan cilexetil for reduction of urinary protein excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in urinary protein/creatinine ratio from baseline to the end of 28-week treatment
Condition | Intervention | Phase |
---|---|---|
Non-Diabetic Nephropathy With Hypertension |
Drug: Candesartan Cilexetil Drug: Candesartan Cilexetil 32mg |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 28-Week, Randomised, Open-Label, Parallel-Group, Multi-Center Study To Find the Effective Dose of Candesartan Cilexetil (Atacand) for Renoprotection in Korean Hypertensive Patients With Non-Diabetic Nephropathy |
Estimated Enrollment: | 139 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Candesartan Cilexetil 8mg
|
Drug: Candesartan Cilexetil
8 mg oral once daily dose
|
2: Experimental
Candesartan Cilexetil 16mg
|
Drug: Candesartan Cilexetil
16 mg oral once daily dose
|
3: Experimental
Candesartan Cilexetil 32mg
|
Drug: Candesartan Cilexetil 32mg
32 mg oral once daily dose
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: AstraZeneca Korea Clinical Study, Information | 82 2 2188 0951 | minjee.nam@astrazeneca.com |
Contact: Dae Suk Han | 82 2 2228 1937 | dshan@yumc.yonsei.ac.kr |
Korea, Republic of | |
Research Site | Recruiting |
Seoul, Korea, Republic of |
Principal Investigator: | Da Suk Han | Severance Hospital |
Responsible Party: | AstraZeneca ( Established Product Medical Science Director ) |
Study ID Numbers: | D2452L00015 |
Study First Received: | December 13, 2007 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00573430 |
Health Authority: | Korea: Food and Drug Administration |
Candesartan Cilexetil Non-diabetic Nephropathy hypertension urine protein creatinine ratio |
Candesartan cilexetil Urologic Diseases Candesartan Vascular Diseases |
Kidney Diseases Angiotensin II Hypertension |
Angiotensin II Type 1 Receptor Blockers Molecular Mechanisms of Pharmacological Action Therapeutic Uses Cardiovascular Diseases |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |