Ignite Creation Date:
2024-05-05 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00738660
Status:
COMPLETED
Last Update Posted:
2008-08-20
First Post:
2008-08-18
Brief Title:
Efficacy of Telmisartan and the Combination of Telmisartan and Ramipril in type1 Diabetes Patients With Nephropathy
Sponsor:
Post Graduate Institute of Medical Education and Research Chandigarh
Organization:
PIMERIndia
Study Overview
Official Title:
Efficacy of Telmisartan and the Combination of Telmisartan and Ramipril in type1 Diabetes Patients With Nephropathy
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
START1DM
Brief Summary:
Hypothesis
The angiotensin receptor blocker telmisartan is effective at reduction of albumin excretion rateAER 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
The angiotensin receptor blocker telmisartan is effective at reduction of albumin excretion rateAER 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
Detailed Description:
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 macroalbuminuriaTo 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 43 The albumin excretion rateAER 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 before14 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
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 43 The albumin excretion rateAER 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 before14 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None