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Pharmacogenetics of Ace Inhibitor-Associated Angioedema

NCT01413542 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2015-11-04

Study results available
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Summary

The investigators would like to find out if sitagliptin (dipeptidyl peptidase-4 or DPP4 inhibition), a drug to treat diabetes, affects blood vessel relaxation in healthy people receiving enalapril (angiotensin converting enzyme or ACE inhibition), a blood pressure medicine. Understanding how these drugs interact in healthy people will help us learn their potential effects in people who have diabetes.

Conditions

Interventions

DRUG

Sitagliptin (DPP4 inhibitor)

Sitagliptin 200 mg (DPP4 inhibitor) or matching placebo will be given one hour prior to intra-arterial infusions

DRUG

Substance P,

Substance P intra-brachial artery (2,4,8 pmol/min)

DRUG

bradykinin

bradykinin intra-brachial artery (23.6, 47.2, and 94.3 pmol/min)

DRUG

enalaprilat (ACE inhibitor)

intra-brachial artery(0.33 µg/min per 100 mL forearm volume)

DRUG

Glucagon-like peptide 1

intra-brachial artery (0.45-3.60 pmol/min)

DRUG

brain natriuretic peptide

Intra-brachial artery (0.90, 1.80 and 3.6 pmol/min)

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Nancy J Brown, MD · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01413542 on ClinicalTrials.gov