| Trial ID: | L2234 |
| Source ID: | NCT00535925
|
| Associated Drug: |
Soc Therapy
|
| Title: |
Nephropathy In Type 2 Diabetes and Cardio-renal Events
|
| Acronym: |
NID-2
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00535925/results
|
| Conditions: |
Diabetic Nephropathy
|
| Interventions: |
DRUG: SoC therapy|DRUG: irbesartan|DRUG: ramipril|DRUG: hydrochlorothiazide|DRUG: furosemide|DRUG: amlodipine|DRUG: atenolol|DRUG: doxazosin|DRUG: clonidine|DRUG: insulin|DRUG: simvastatin|DRUG: fibrate|DRUG: erythropoietin|DRUG: aspirin
|
| Outcome Measures: |
Primary: "Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs)", number of MACEs in the two groups are reported. In addition, The primary endpoint was analyzed with event curves for the time-to-first event based on Kaplan-Meier analysis. Cox regression model was used to calculate hazard ratio (HR) and 95% Confidence Interval (CI). Due to the cluster randomized study design, a Cox shared-frailty model was fitted. multivariable model was adjusted for selected potential confounders: age, sex, systolic blood pressure (SBP), hemoglobin, estimated glomerular filtration rate (eGFR), albuminuria, HbA1c, total cholesterol and triglycerides (log-scaled) to reduce risk of bias., 4 years (in the case the number of events needed by sample size is not reached at the expected 4-year time frame, primary end point will be assessed after the follow-up phase) | Secondary: "Number of Participants Who Achieved of BP, HbA1c and Total, HDL and LDL Cholesterol Goals at the End of Intervention Phase", Achievement of targets at end of intervention was performed applying generalized estimating equation (GEE) models, further adjusting for baseline values as covariate., 13 years
|
| Sponsor/Collaborators: |
Sponsor: University of Campania Luigi Vanvitelli
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
850
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
2005-10
|
| Completion Date: |
2019-05
|
| Results First Posted: |
2020-05-11
|
| Last Update Posted: |
2020-08-03
|
| Locations: |
Department of Advanced Medical and Surgical Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy, Naples, I-80131, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT00535925
|
