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Completed

NCT Number: NCT00240422

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Boehringer Ingelheim Investigational Site, Lyon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

Telmisartan

Drug

Ramipril

Drug

Primary outcomes

  1. Change from baseline of renal plasma flow (RPF) in response to L-NMMA infusion at the end of treatment.

    Time frame: 9 weeks

Secondary outcomes

  1. Change from baseline of glomerular filtration rate (GFR) in response to L-NMMA infusion at the end of treatment

    Time frame: 9 weeks

  2. Change from baseline of filtration fraction (FF) in response to L-NMMA infusion at the end of treatment.

    Time frame: 9 weeks

  3. Change from baseline of renal vascular resistance (RVR) in response to L-NMMA infusion at the end of treatment.

    Time frame: 9 weeks

  4. Change from baseline of RPF in response to L-arginine infusion at the end of treatment.

    Time frame: 9 weeks

  5. Change from baseline of GFR in response to L-arginine infusion at the end of treatment

    Time frame: 9 weeks

  6. Change from baseline of FF in response to L-arginine infusion at the end of treatment.

    Time frame: 9 weeks

  7. Change from baseline of RVR in response to L-arginine infusion at the end of treatment.

    Time frame: 9 weeks

  8. 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

  9. Change from baseline of MAP and PR in response to L-arginine infusion at the end of treatment.

    Time frame: 9 weeks

  10. 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

  11. Change from baseline of the pre-L-NMMA RPF at the end of treatment

    Time frame: 9 weeks

  12. Change from baseline of the pre-L-NMMA GFR at the end of treatment

    Time frame: 9 weeks

  13. Change from baseline of the pre-L-NMMA FF at the end of treatment.

    Time frame: 9 weeks

  14. Change from baseline of the pre-L-NMMA RVR at the end of treatment.

    Time frame: 9 weeks

  15. Change from baseline of the urinary excretion parameters creatinine, sodium, potassium, and urea at the end of treatment.

    Time frame: 9 weeks

  16. Blood pressure response and control at the end of treatment

    Time frame: 9 weeks

  17. Change from baseline of central blood pressure and augmentation index (by pulse wave analysis) at the end of treatment.

    Time frame: 9 weeks

  18. Change from baseline of RPF in response to Vitamin C infusion at the end of treatment

    Time frame: 9 weeks

  19. Change from baseline of GFR in response to Vitamin C infusion at the end of treatment

    Time frame: 9 weeks

  20. Change from baseline of FF in response to Vitamin C infusion at the end of treatment.

    Time frame: 9 weeks

  21. Change from baseline of RVR in response to Vitamin C infusion at the end of treatment.

    Time frame: 9 weeks

  22. Change from baseline of MAP and PR in response to Vitamin C infusion at the end of treatment.

    Time frame: 9 weeks

  23. Incidence of adverse events

    Time frame: week -2 and 9 weeks

  24. Changes from base line in routine laboratory data at the end of the study

    Time frame: 9 weeks

  25. Changes in vital signs

    Time frame: 9 weeks

  26. Changes from screening in physical examination at the end of the study

    Time frame: - 4 weeks and 9 weeks

  27. Changes from screening in ECG at the end of the study

    Time frame: - 4 weeks and 9 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2004
First posted
Oct 18, 2005
Registry last updated
Nov 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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