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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 4, 2006 | ||||||||
| Last Updated Date | April 4, 2006 | ||||||||
| Start Date ICMJE | March 1993 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
change in glomerular filtration rate from study start to study end | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy | ||||||||
| Official Title ICMJE | |||||||||
| Brief Summary | The aim of the study was to compare the renoprotective effect of a long acting calcium antagonist (nisoldipine) with an angiotensin converting enzyme inhibitor (lisinopril)in type 1 diabetic patients with diabetic kidney disease. In total, 51 patients were randomised to treatment with one of these drugs for 4 years. Changes in kidney function, blood pressure and urinary excretion of albumin were measured every 6 months |
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| Detailed Description | - |
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| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Diabetic Nephropathy | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | Tarnow L, Rossing P, Jensen C, Hansen BV, Parving HH. Long-term renoprotective effect of nisoldipine and lisinopril in type 1 diabetic patients with diabetic nephropathy. Diabetes Care. 2000 Dec;23(12):1725-30. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 52 | ||||||||
| Completion Date | April 1999 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 55 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Denmark | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00311870 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | KA 92126 | ||||||||
| Study Sponsor ICMJE | Steno Diabetes Center | ||||||||
| Collaborators ICMJE | Bayer | ||||||||
| Investigators ICMJE |
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| Information Provided By | Steno Diabetes Center | ||||||||
| Verification Date | April 1999 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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