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
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
1 other identifier
interventional
96
3 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 diabetes-mellitus-type-2
Started Feb 2003
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 14, 2005
CompletedFirst Posted
Study publicly available on registry
October 18, 2005
CompletedNovember 8, 2013
November 1, 2013
October 14, 2005
November 7, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline of renal plasma flow (RPF) in response to L-NMMA infusion at the end of treatment.
9 weeks
Secondary Outcomes (27)
Change from baseline of glomerular filtration rate (GFR) in response to L-NMMA infusion at the end of treatment
9 weeks
Change from baseline of filtration fraction (FF) in response to L-NMMA infusion at the end of treatment.
9 weeks
Change from baseline of renal vascular resistance (RVR) in response to L-NMMA infusion at the end of treatment.
9 weeks
Change from baseline of RPF in response to L-arginine infusion at the end of treatment.
9 weeks
Change from baseline of GFR in response to L-arginine infusion at the end of treatment
9 weeks
- +22 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Hypertensive patients aged 30-80 years with type 2 diabetes, normo- or microalbuminuria, GFR \> 80 mL/min (Cockroft-Gault)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Boehringer Ingelheim Investigational Site
Lyon, France
Boehringer Ingelheim Investigational Site
Montpellier, France
Friedrich-Alexander-Universität
Erlangen, 91054, Germany
Boehringer Ingelheim Investigational Site
Nuremberg, 90402, Germany
Universität Erlangen-Nürnberg
Nuremberg, 90471, Germany
Edificio de Medicina Comunitaria
Madrid, 28041, Spain
Related Publications (1)
Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.
PMID: 38682786DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim Study Coordinator
B.I. Pharma GmbH & Co. KG
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 14, 2005
First Posted
October 18, 2005
Study Start
February 1, 2003
Study Completion
July 1, 2004
Last Updated
November 8, 2013
Record last verified: 2013-11