NCT00311974

Brief Summary

We, the investigators at Holstebro Hospital, want to test the hypothesis that dihydralazine leads to the activation of the sympathetic nervous system in healthy individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_4 healthy

Timeline
Completed

Started Apr 2006

Typical duration for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2006

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 7, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

February 18, 2010

Status Verified

February 1, 2010

Enrollment Period

1.6 years

First QC Date

April 5, 2006

Last Update Submit

February 17, 2010

Conditions

Healthy

Keywords

DihydralazineSympathetic activationFractional sodium excretion

Outcome Measures

Primary Outcomes (3)

  • Fractional sodium excretion

  • Heart rate

  • Blood pressure

Interventions

DihydralazineDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men
  • Ages 18 to 40 years.
  • Body mass index less than or equal to 30 kg/m2

You may not qualify if:

  • History or clinical signs of heart, lung, kidney, or endocrine organ disease.
  • Abnormal biochemical screening of the blood regarding: B-hemoglobin, P-sodium, P-potassium, P-creatinine, P-albumin, P-bilirubin, P-alanine aminotransferase, P-alkaline phosphatase, P-cholesterol, and B-glucose.
  • Abnormal screening of the urine regarding: albumin and glucose
  • Malignant disease.
  • Known arterial hypertension or measured 24 hour blood pressure above 135 mmHg systolic or 85 mmHg diastolic.
  • Alcohol abuse.
  • Smoking.
  • Drug use or abuse.
  • Known intolerance or allergy to dihydralazine
  • Blood donation within 1 month of the start of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Research, Holstebro Hospital

Holstebro, 7500, Denmark

Location

MeSH Terms

Interventions

Dihydralazine

Intervention Hierarchy (Ancestors)

HydralazinePhthalazinesPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Erling B Pedersen, Professor

    Department of Medical Research, Holstebro Hospital, Denmark

    STUDY CHAIR

  • Henrik Vase, MD

    Department of Medical Research, Holstebro Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 5, 2006

First Posted

April 7, 2006

Study Start

April 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

February 18, 2010

Record last verified: 2010-02

Locations

DK(1)