MedTrace Logo

L-NMMA Dose-response Study in Healthy Subjects

NCT01070940 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2011-02-21

No results posted yet for this study

Summary

The purpose of this study is to investigate the effect of different levels of nitric oxide inhibition on blood pressure and arterial stiffness in healthy subjects. L-NMMA, an inhibitor of the nitric oxide synthase, is administered as bolus injection followed by continuous infusion, and is expected to raise blood pressure and arterial stiffness according to L-NMMA dose.

Conditions

  • Healthy

Interventions

DRUG

NG-monomethyl-L-arginine (L-NMMA)

3 mg/kg IV priming dose + 2 mg/kg/hr IV infusion for 1 hour

DRUG

NG-monomethyl-L-arginine (L-NMMA)

6 mg/kg IV priming dose + 4 mg/kg/hr IV infusion for 1 hour

DRUG

NG-monomethyl-L-arginine (L-NMMA)

4.5 mg/kg IV priming dose + 3 mg/kg/hr IV infusion for 1 hour

DRUG

Placebo

Isotonic saline solution IV priming dose + IV infusion for 1 hour

Sponsors & Collaborators

  • Regional Hospital Holstebro

    lead OTHER

Principal Investigators

  • Thomas Larsen, M.D. · Departments of Medical Research, Holstebro Hospital

  • Frank H Christensen, M.D. · Departments of Medical Research, Holstebro Hospital

  • Erling B Pedersen, Dr.med. · Departments of Medical Research, Holstebro Hospital

  • Jesper N Bech, Ph.d. · Departments of Medical Research, Holstebro Hospital

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

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 NCT01070940 on ClinicalTrials.gov