The Effect of Dihydralazine on Kidney Function and Hormon... | NCT00311974

Studies
The Effect of Dihydralazine on Kidney Function and Hormones in Healthy Individuals

NCT00311974

Sponsor

Regional Hospital Holstebro

Status

Completed

Last Update Posted

Feb 18, 2010Estimated

Enrollment

Phase

Phase 4

Conditions

Healthy

Interventions

Dihydralazine

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
99127500

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Nov 2007Actual

Completion Date

Nov 2007Actual

First Submitted Date

Apr 5, 2006

First Submission Date that Met QC Criteria

Apr 5, 2006

First Posted Date

Apr 7, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2010

Last Update Posted Date

Feb 18, 2010Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Dihydralazine	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medical Research, Holstebro Hospital		Holstebro		7500	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D004078	Dihydralazine

Ancestor Terms

ID	Term
D006830	Hydralazine
D010793	Phthalazines
D011724	Pyridazines
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Fractional sodium excretion
Heart rate
Blood pressure