NCT00345150

Brief Summary

The study tests the hypothesis that systemic and renal nitric oxide synthesis is changed in essential hypertension by investigating the effects of a non selective nitric oxide inhibitor on renal hemodynamics and sodium excretion in patients with essential hypertension. The results are compared with a group of healthy subjects.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
Last Updated

June 27, 2006

Status Verified

June 1, 2006

First QC Date

June 24, 2006

Last Update Submit

June 24, 2006

Conditions

Hypertension

Keywords

hypertensionnitric oxiderenal hemodynamics

Interventions

Ng-monomethyl-L-arginine (drug)DRUG

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Essential hypertension (blood pressure \> 140/90) with no signs of secondary hypertension
  • P-creatinine \< 200 µmol/L

You may not qualify if:

  • Anamnestic or clinical signs of heart disease, renal disease, liver disease, neoplastic disease, anemia or cerebro-vascular insult
  • Medication except antihypertensives
  • Drug or alcohol abuse
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

omega-N-MethylargininePharmaceutical Preparations

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ArginineAmino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Essential

Study Officials

  • Jesper N Bech, MD, Ph.D.

    Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark

    PRINCIPAL INVESTIGATOR

  • Erling B Pedersen, Professor

    Holstebro Hospital, 7500 Holstebro, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 24, 2006

First Posted

June 27, 2006

Last Updated

June 27, 2006

Record last verified: 2006-06