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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00153023 |
The general aim of this study is to compare telmisartan 80 mg with valsartan 160 mg in hypertensive patients with type 2 diabetes and overt nephropathy with adjusted blood pressure beyond the target of 130/80 mmHg after one year of treatment.
The primary objective of this study is to show that telmisartan 80 mg is at least as effective (i.e., not inferior) and possibly superior to valsartan 160 mg in reducing 24 hour proteinuria after one year of treatment.
Condition | Intervention | Phase |
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Diabetic Nephropathies Hypertension |
Drug: Telmisartan Drug: Valsartan |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Randomised, Double-Blind, Double-Dummy, Forced-Titration, Multicentre, Parallel Group, One Year Treatment Trial to Investigate the Efficacy of Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy |
Estimated Enrollment: | 885 |
Estimated Study Completion Date: | December 2005 |
This is a randomised, double-blind, double-dummy, forced titration, multicentre, parallel group trial in patients with essential hypertension, diabetes mellitus type 2 and diabetic nephropathy.
After a 4-6 week Run-in period, patients are randomised to one of the treatment groups and receive either Telmisartan 40 - 80 mg or Valsartan 80 - 160 mg. The treatment regimen is a forced titration with the lower dose given for 2 weeks and the higher dose given for the rest of the treatment period summing up to 52 weeks of treatment. During the treatment period, 8 visits to the investigator are scheduled in order to control blood pressure, renal function parameters and safety. In addition, parameters of endothelial function and oxidative stress are measured at baseline, 6 months and after one year of treatment.
Study Hypothesis:
Non-inferiority of telmisartan 80 mg compared to valsartan 160 mg will be tested using the following set of hypotheses:
Null Hypothesis:
The overall mean change from baseline in UPER (24 hour urinary protein excretion rate) for telmisartan 80 mg is inferior to that for valsartan 160 mg by 0.5 g/day or more.
Alternative Hypothesis:
The overall mean change from baseline in UPER (24 hour urinary protein excretion rate) for telmisartan 80 mg is less than 0.5 g/day worse than that for valsartan 160 mg.
Comparison(s):
In order to test the non-inferiority hypothesis, analysis of covariance with treatment and centre as main effects and baseline as a covariate will be performed. Time-to-event data will be analysed using the log-rank test.
Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hypertension at screening defined as:
Exclusion Criteria: None
Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. Pharma GmbH & Co. KG |
Study ID Numbers: | 502.396 |
Study First Received: | September 9, 2005 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00153023 |
Health Authority: | Spain: Ministry of Health; Germany: BfArM; Austria: SUKL (state institute for drug control); South Africa: Medicines Control Council; Denmark: Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Italy: Ethics Committee; Portugal: INFARMED; Taiwan: Department of Health; Austria: Ministry of Health Crae of Ukraine (MoH of Ukraine); South Korea: Korea Food and Drug Administration (KFDA); Malaysia: Ministry of Health, National Pharmaceutical Control Bureau (NPCB), 6 main ECs |
Diabetic Nephropathies Urologic Diseases Vascular Diseases Diabetes Mellitus Endocrine System Diseases Telmisartan |
Endocrinopathy Kidney Diseases Angiotensin II Valsartan Diabetes Complications Hypertension |
Angiotensin II Type 1 Receptor Blockers Molecular Mechanisms of Pharmacological Action Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Enzyme Inhibitors |
Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors |