Effects of Inhibition of NO-Synthesis on Renal Hemodynami... | NCT00345150

Studies
Effects of Inhibition of NO-Synthesis on Renal Hemodynamics and Sodium Excretion in Patients With Essential Hypertension and Healthy Controls

NCT00345150

Sponsor

Regional Hospital Holstebro

Status

Completed

Last Update Posted

Jun 27, 2006Estimated

Enrollment

Phase

Phase 1

Conditions

Hypertension

Interventions

Ng-monomethyl-L-arginine (drug)

Countries

Not provided

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

Status Module

Record Verification Date

Jun 2006

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 24, 2006

First Submission Date that Met QC Criteria

Jun 24, 2006

First Posted Date

Jun 27, 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

Jun 24, 2006

Last Update Posted Date

Jun 27, 2006Estimated

Description Module

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.

Detailed Description

The study investigates the effects of Ng-monomethyl-L-arginine (L-NMMA) on:

renal hemodynamics (renal plasma flow and glomerular filtration rate)
renal sodium excretion
lithium clearance and fractional lithium excretion
plasma levels of vasoactive hormones
blood pressure and heart rate

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Ng-monomethyl-L-arginine (drug)	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Not provided

ID	Term
D006973	Hypertension

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D019323	omega-N-Methylarginine
D004364	Pharmaceutical Preparations

Ancestor Terms

ID	Term
D001120	Arginine
D024361	Amino Acids, Basic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided