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Sponsored by: |
Postgraduate Institute of Medical Education and Research |
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Information provided by: | Postgraduate Institute of Medical Education and Research |
ClinicalTrials.gov Identifier: | NCT00738660 |
Hypothesis:
The angiotensin receptor blocker telmisartan is effective at reduction of albumin excretion rate(AER) in patients with type1 diabetes and micro or macroalbuminuria. Dual blockade with the addition of ramipril an angiotensin receptor blocker gives added efficacy for reduction of AER. ARB telmisartan gives a 24 hr BP lowering effect.
Summary:
This is an open label cross over study involving 30 patients who were initially treated with Telmisartan 80 mg for eight weeks followed by addition of Ramipril 10 mg for a further eight weeks. Albuminuria reduction and BP reduction with both clinic and ambulatory BP records were studied at the end of each phase.
Condition | Intervention | Phase |
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Diabetic Nephropathy |
Drug: Telmisartan, Ramipril |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study |
Official Title: | Efficacy of Telmisartan and the Combination of Telmisartan and Ramipril in type1 Diabetes Patients With Nephropathy |
Enrollment: | 30 |
Study Start Date: | February 2007 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
single experimental arm cross over of patients, addition of Ramipril onto Telmisartan.
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Drug: Telmisartan, Ramipril
80 mg of telmisartan administered for 8weeks,followed by addition of ramipril 10 mg for further 8weeks
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To evaluate the antialbuminuric efficacy of an angiotensin receptor blocker (ARB) telmisartan and the combination of telmisartan and ramipril in patients with type1 DM and either micro or macroalbuminuria.To evaluate the same drugs for their antihypertensive efficacy and their influence on dipping patterns using ambulatory BP monitoring.
Methods:
Open label cross over study involving 30 patients who were initially treated with telmisartan 80 mg for eight weeks followed by addition of ramipril 10 mg for a further eight weeks. Albuminuria reduction and BP reduction with both clinic and ambulatory BP records were studied at the end of each phase Overnight urine samples of nine hours duration were collected . The volume of urine was verified by measurement in a jar with accuracy of 50ml by the study investigator on every occasion. . Albuminuria was estimated by immuno-turbidimetry Hemocue albumin system Angelholm AD, Sweden (inter assay CV 4.3% ). The albumin excretion rate(AER) at baseline evaluation was determined as the mean AER of the positive urine samples. During subsequent evaluations at the end of 8weeks and at the end of 16 weeks the mean albumin excretion rate from two successive overnight urine samples was taken as the mean .Ambulatory BP (ABP) measurement :ABP was measured using Spacelabs device 90207 Spacelabs inc. use of which is described before(14) .A uniform protocol of inflation once in every 30 min was used. Cuff was applied to the nondominant arm. Recordings were started in all patients between seven and ten AM.
Ages Eligible for Study: | 14 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
India | |
Post Graduate Institute of Medical Education and Research | |
chandigarh, India, 1600012 |
Principal Investigator: | sanjay k bhadada, DM | post graduate institute of medical education and research |
Responsible Party: | Post graduaate institute of medical education and research ( Sanjay K Bhadada ) |
Study ID Numbers: | START1DM |
Study First Received: | August 18, 2008 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00738660 |
Health Authority: | India: Institutional Review Board |
type1 DM microalbuminuria nephropathy albumin excretion rate |
dual blockade ACEI ARB |
Diabetic Nephropathies Metabolic Diseases Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Angiotensin II Ramipril Diabetes Mellitus, Type 1 |
Urologic Diseases Telmisartan Kidney Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic disorder Diabetes Complications |
Angiotensin II Type 1 Receptor Blockers Molecular Mechanisms of Pharmacological Action Immune System Diseases Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors |
Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors |