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| Descriptive Information Fields | |||||
| Brief Title † | INNOVATION Study - Telmisartan (Micardis?) in Incipient Diabetic Nephropathy | ||||
| Official Title † | A Randomised, Double-Blind, Placebo-Controlled, Multicenter Trial to Investigate the Preventive Effect of BIBR277 (Telmisartan) in Diabetic Nephropathy on Transition From Incipient to Overt Nephropathy - Incipient to Overt : Angiotensin 2 Receptor Blocker, Telmisartan, Investigation on Type 2 Diabet | ||||
| Brief Summary | The aim of this study is to compare the preventive effect of Telmisartan (Micardis?) versus placebo control on the transition to overt nephropathy in patients with diabetic nephropathy manifesting mic roalbuminuria associated with type II diabetes, and to evaluate the efficacy and safety of Telmisart an (Micardis?, Gliosartan?, Kinzal?, Kinzalmono?, Predxal?, Pritor?, Samertan?, Telmisartan?) for di abetic nephropathy patients. |
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| Detailed Description | A prospective, randomised, double-blind, multicentric and comparative study to investigate, on a lon g-term basis, the preventive effect on the transition to overt nephropathy and the safety of Telmisa rtan (Micardis?) against placebo in patients with diabetic nephropathy, manifesting microalbuminuria associated with type II diabetes Study Hypothesis: The hypothesis is that Telmisartan (Micardis?) at 40 mg or 80 mg versus placebo control in patients with concurrent type II diabetic mellitus or diabetic nephro pathy demonstrating microalbuminuria, has the preventive effect on transition fr om incipient to overt nephropathy. Comparison(s): The primary endpoint is defined as the transition from incipient to overt nephro pathy, and the non-transition curve will be demonstrated based on the Kaplan-Mei er method. The evaluation criteria for the point to transition to overt nephropa thy is defined as urinary albumin to creatinine ratios at consecutive 2 measurin g points increasing over 300 mg/g-Creatinine and excess 30% increase comparing w ith the baseline value. The curve of non-transition will be compared with Logran k test. Those in BIBR277 groups are sequentially compared with that in the place bo group by the closed testing procedure. |
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| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Non-transition to overt nephropathy | ||||
| Secondary Outcome Measure † | Change in renal parameters Composite endpoint | ||||
| Condition † | Diabetic Nephropathies | ||||
| Intervention † | Drug: Telmisartan capsule 40 mg Drug: Placebo Drug: Telmisartan capsule 80 mg |
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| MEDLINE PMIDs | |||||
| Links | Related Info ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 450 | ||||
| Start Date † | |||||
| Completion Date | November 2005 | ||||
| Eligibility Criteria † | Those who satisfy all the following conditions are eligible:
Patients who do not fall under any one of the following are eligible:
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| Gender | Both | ||||
| Ages | 30 Years to 74 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | Japan | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00153088 | ||||
| Organization ID | 502.413 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Boehringer Ingelheim Pharmaceuticals | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Boehringer Ingelheim Pharmaceuticals | ||||
| Verification Date | March 2008 | ||||
| First Received Date † | September 9, 2005 | ||||
| Last Updated Date | April 3, 2008 | ||||