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Clinical Trial Details

Trial ID: L4565
Source ID: NCT00274118
Associated Drug: Telmisartan
Title: DETAIL Study: Diabetes Exposed to Telmisartan and Enalapril
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Hypertension|Diabetes Mellitus, Type 2
Interventions: DRUG: telmisartan|DRUG: enalapril
Outcome Measures: Primary: Change from baseline in glomerular filtration rate GFR after five years of treatment., 5 years | Secondary: Change from baseline in GFR after one, two, three and four years of treatment, Baseline, 1,2,3 and 4 years|Percentage change from baseline in urinary albumin excretion rate, up to 5 years|Change from baseline in creatinine, up to 5 years|Incidence of clinical endpoints (including- end-stage renal disease, myocardial infarction, cerebrovascular accident, congestive heart failure), up to 5 years|Incidence of all cause mortality, up to 5 years|Changes in vital signs (DBP, SBP, pulse rate), up to 5 years|Number of patients with Adverse Events, up to 5 years|Physical examination, up to 5 years|Clinical laboratory parameters, up to 5 years|Resting 12-lead ECG, up to 5 years
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 250
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: PREVENTION
Start Date: 1997-07
Completion Date: 2004-01
Results First Posted:
Last Update Posted: 2013-11-01
Locations: Boehringer Ingelheim Investigational Site, Frederiksberg C, DK-1900, Denmark|Apopleksiafsnittet, Frederiksberg, DK-2000, Denmark|Lungemedicinsk Forskning, Hellerup, DK-2900, Denmark|Medical Dept. B0642, Hillerød, DK-3400, Denmark|Hvidovre Hospital, Hvidovre, DK-2650, Denmark|Gynækologisk/obstetrisk afd., Kolding, 6000, Denmark|Boehringer Ingelheim Investigational Site, Hyvinkää, 05850, Finland|Boehringer Ingelheim Investigational Site, Jyväskylä, FIN-40100, Finland|Kuopion yliopistollinen sairaala, Keuhkoklinikka, Kuopio, FI-70211, Finland|Boehringer Ingelheim Investigational Site, Riihimäki, 11100, Finland|Boehringer Ingelheim Investigational Site, Tampere, 33520, Finland|Bosch Medicentrum, Den Bosch, 5223 GV, Netherlands|Dept. of Internal Medicine, Utrecht, 3584 CX, Netherlands|Boehringer Ingelheim Investigational Site, Arendal, N-4841, Norway|Boehringer Ingelheim Investigational Site, Jessheim, N-2050, Norway|Boehringer Ingelheim Investigational Site, Skogn, N-7620, Norway|Hjertelaget Research Foundation, Stavanger, N-4011, Norway|Medicinkliniken, Eksjö, 575 81, Sweden|Medicinkliniken, Helsingborg, 251 87, Sweden|Boehringer Ingelheim Investigational Site, Helsingborg, 254 67, Sweden|Boehringer Ingelheim Investigational Site, Munkedal, 455 30, Sweden|Boehringer Ingelheim Investigational Site, Tranås, 573 83, Sweden|Boehringer Ingelheim Investigational Site, Uddevalla, 451 40, Sweden|Samariterhemmets sjukhus, Uppsala, 751 25, Sweden|Boehringer Ingelheim Investigational Site, Vetlanda, 574 28, Sweden|Boehringer Ingelheim Investigational Site, Atherstone, CV9 1EU, United Kingdom|Boehringer Ingelheim Investigational Site, Barry, CF62 7EB, United Kingdom|Dept. of Diabetes, Birmingham, B18 7QH, United Kingdom|Department of Respiratory Medicine, Birmingham, B9 5SS, United Kingdom|Royal Bournemouth Hospital, Bournemouth, BH7 7DW, United Kingdom|Finance Office (Research Unit), Newcastle-Upon-Tyne, NE1 7RU, United Kingdom|Northampton General Hospital, Northampton, NN1 5BD, United Kingdom|Boehringer Ingelheim Investigational Site, Northampton, NN5 7AQ, United Kingdom|Diabetes Centre,, Nuneaton,, CV10 7DJ, United Kingdom|Lucille Packard Children's Health Services at Stanford, Palo Alto, 94304-5786, United Kingdom|Boehringer Ingelheim Investigational Site, Pontyclun, CF72 9AA, United Kingdom|Diabetes Centre, Rugby, CV22 5PX, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00274118