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Trial to Compare the Effects of Either Telmisartan (40-80 mg PO Once Daily) or Ramipril (5-10 mg PO Once Daily) on Renal Endothelial Dysfunction in Hypertensive Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00240422
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : November 8, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE October 14, 2005
First Posted Date  ICMJE October 18, 2005
Last Update Posted Date November 8, 2013
Study Start Date  ICMJE February 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2013)
Change from baseline of renal plasma flow (RPF) in response to L-NMMA infusion at the end of treatment. [ Time Frame: 9 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2005)
Change in RPF from baseline (Visit 4) to the end of treatment (Visit 7) in response to L-NMMA infusion
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2013)
  • Change from baseline of glomerular filtration rate (GFR) in response to L-NMMA infusion at the end of treatment [ Time Frame: 9 weeks ]
  • Change from baseline of filtration fraction (FF) in response to L-NMMA infusion at the end of treatment. [ Time Frame: 9 weeks ]
  • Change from baseline of renal vascular resistance (RVR) in response to L-NMMA infusion at the end of treatment. [ Time Frame: 9 weeks ]
  • Change from baseline of RPF in response to L-arginine infusion at the end of treatment. [ Time Frame: 9 weeks ]
  • Change from baseline of GFR in response to L-arginine infusion at the end of treatment [ Time Frame: 9 weeks ]
  • Change from baseline of FF in response to L-arginine infusion at the end of treatment. [ Time Frame: 9 weeks ]
  • Change from baseline of RVR in response to L-arginine infusion at the end of treatment. [ Time Frame: 9 weeks ]
  • Change from baseline of mean arterial pressure (MAP) and pulse rate (PR) in response to L-NMMA infusion at the end of treatment. [ Time Frame: 9 weeks ]
  • Change from baseline of MAP and PR in response to L-arginine infusion at the end of treatment. [ Time Frame: 9 weeks ]
  • Change from baseline of the laboratory parameters angiotensin II (ANG II), aldosterone, asymmetrical dimethylarginine (ADMA), L-arginine, urinary nitrate/nitrite (UNOx), and urinary albumin excretion at the end of treatment [ Time Frame: 9 weeks ]
  • Change from baseline of the pre-L-NMMA RPF at the end of treatment [ Time Frame: 9 weeks ]
  • Change from baseline of the pre-L-NMMA GFR at the end of treatment [ Time Frame: 9 weeks ]
  • Change from baseline of the pre-L-NMMA FF at the end of treatment. [ Time Frame: 9 weeks ]
  • Change from baseline of the pre-L-NMMA RVR at the end of treatment. [ Time Frame: 9 weeks ]
  • Change from baseline of the urinary excretion parameters creatinine, sodium, potassium, and urea at the end of treatment. [ Time Frame: 9 weeks ]
  • Blood pressure response and control at the end of treatment [ Time Frame: 9 weeks ]
  • Change from baseline of central blood pressure and augmentation index (by pulse wave analysis) at the end of treatment. [ Time Frame: 9 weeks ]
  • Change from baseline of RPF in response to Vitamin C infusion at the end of treatment [ Time Frame: 9 weeks ]
  • Change from baseline of GFR in response to Vitamin C infusion at the end of treatment [ Time Frame: 9 weeks ]
  • Change from baseline of FF in response to Vitamin C infusion at the end of treatment. [ Time Frame: 9 weeks ]
  • Change from baseline of RVR in response to Vitamin C infusion at the end of treatment. [ Time Frame: 9 weeks ]
  • Change from baseline of MAP and PR in response to Vitamin C infusion at the end of treatment. [ Time Frame: 9 weeks ]
  • Incidence of adverse events [ Time Frame: week -2 and 9 weeks ]
  • Changes from base line in routine laboratory data at the end of the study [ Time Frame: 9 weeks ]
  • Changes in vital signs [ Time Frame: 9 weeks ]
  • Changes from screening in physical examination at the end of the study [ Time Frame: - 4 weeks and 9 weeks ]
  • Changes from screening in ECG at the end of the study [ Time Frame: - 4 weeks and 9 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2005)
Change from baseline in - Renal function parameters before and in response to L-NMMA and L-arginine hydrochloride infusion; - angiotensin II, aldosterone, ADMA, L-arginine - urinary excretion parameters - blood pressure, augmentation index
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Compare the Effects of Either Telmisartan (40-80 mg PO Once Daily) or Ramipril (5-10 mg PO Once Daily) on Renal Endothelial Dysfunction in Hypertensive Patients With Type 2 Diabetes
Official Title  ICMJE A Prospective, Randomized, Double-blind, Double-dummy, Forced Titration, Parallel Group Comparison, Multicenter Trial to Compare the Effects of Either Telmisartan (40-80 mg p.o. Once Daily) or Ramipril (5-10 mg p.o. Once Daily) on Renal Endothelial Dysfunction in Hypertensive Patients With Type 2 Diabetes
Brief Summary The primary objective is to evaluate the effect of 9 weeks treatment with either telmisartan or ramipril on NO bioavailability in the renal vasculature, measured as renal plasma flow (RPF) in response to NG-monomethyl-L-arginine (LNMMA) infusion.
Detailed Description

This study was designed as a randomised, double-blind, double-dummy, parallel group in hypertensive patients with type 2 diabetes and normo- or microalbuminuria over a treatment period of 9 weeks.

After a 4 week Run-in period, patients will be randomised to one of the treatment groups and receive either Telmisartan 40 - 80 mg or Ramipril 5 - 10 mg. The treatment regimen is a forced titration with the lower dose given for 3 weeks and the higher dose given for the rest of the treatment period summing up to 9 weeks of treatment. During the treatment period, 3 visits to the investigator will be scheduled in order to control blood pressure, renal function parameters and safety. In addition, parameters of endothelial function in the renal vasculature, based on a nephrological clearance investigation and a provocation with L-NMMA will be measured at baseline and after 9 weeks of treatment.

Study Hypothesis:

Due to the exploratory nature of the trial, the primary objective to evaluate the effect on RPF in response to L-NMMA infusion at baseline and after 9 weeks of therapy with either telmisartan 80 mg or ramipril 10 mg was not planned to be addressed by a test of prespecified hypotheses.

Comparison(s):

The change in RPF from baseline (Visit 4) to the end of treatment (Visit 7) in response to L-NMMA infusion was to be calculated as the change from the pre L-NMMA infusion (S1) to the end of the L-NMMA infusion (S2). A comparison of treatment groups was to be made using an analysis of covariance (ANCOVA) with pooled centre and treatment included as main effects and RPF (in response to L NMMA infusion) at baseline as a covariate. The treatment group difference, adjusted for the other factors in the model, was to be presented with a corresponding 95% confidence interval (CI) and a test of statistical significance. The model was also to be used to provide analysis results for the within treatment group changes.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Hypertension
Intervention  ICMJE
  • Drug: Telmisartan
  • Drug: Ramipril
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 7, 2013)
96
Original Enrollment  ICMJE
 (submitted: October 14, 2005)
95
Study Completion Date  ICMJE July 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hypertensive patients aged 30-80 years with type 2 diabetes, normo- or microalbuminuria, GFR > 80 mL/min (Cockroft-Gault)

Exclusion Criteria: None

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00240422
Other Study ID Numbers  ICMJE 502.398
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Pharma GmbH & Co. KG
PRS Account Boehringer Ingelheim
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP