The Effect of Eprosartan on Hormones and Kidney Function... | NCT00438945

Studies
The Effect of Eprosartan on Hormones and Kidney Function in Patients With Essential Hypertension

NCT00438945

Sponsor

Regional Hospital Holstebro

Status

Completed

Last Update Posted

May 9, 2008Estimated

Enrollment

18Estimated

Phase

Phase 4

Conditions

Essential Hypertension

Interventions

Eprosartan

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

Status Module

Record Verification Date

May 2008

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

Jan 2007

Primary Completion Date

Not provided

Completion Date

Jan 2008Actual

First Submitted Date

Feb 20, 2007

First Submission Date that Met QC Criteria

Feb 21, 2007

First Posted Date

Feb 22, 2007Estimated

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

May 5, 2008

Last Update Posted Date

May 9, 2008Estimated

Description Module

Brief Summary

We, the investigators at Holstebro Hospital, want to test the hypothesis that eprosartan reduces the activity of the sympathetic nervous system in patients with essential hypertension - during baseline conditions and after activation of the sympathetic nervous system.

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

18Estimated

Name	Type	Description	Arm Group Labels	Other Names
Eprosartan	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Heart rate
Fractional sodium excretion
Plasma levels of noradrenaline

Secondary Outcomes

Measure	Description	Time Frame
Fractional lithium excretion
Glomerular filtration rate
plasma levels of renin, angiotensin II, aldosterone, vasopressin, atrial natriuretic peptide and brain natriuretic peptide

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 - 65 years.
Body mass index less or equal to 30 kg/m2.
Women must use oral hormonal anticonceptive drugs, use intrauterine anticonceptive device, be sterilized / hysterectomized or be postmenopausal.
Arterial hypertension, defined by 24 hour ambulatory blood pressure above 125 mmHg systolic or above 80 mmHg diastolic.

Exclusion Criteria:

History of myocardial infarction.
History of stroke.
Heart failure.
Endocrine organ disease.
Lung disease.
Clinically significant abnormal biochemical screening of the blood regarding: B-hemoglobin, P-sodium, P-potassium, P-creatinine (under 200 µmol/L will be accepted), P-albumin, p-bilirubin, p-alaninaminotransferase, P-alkaline phosphatase, p-cholesterol and B-glucose.
Clinically significant abnormal screening of the urine regarding: albumin and glucose (protein excretion below 0.5 g/L will be accepted).
Renovascular hypertension.
Malignant disease.
Alcohol abuse.
Usage of medical drugs besides antihypertensives or statins.
Drug abuse.
Pregnancy or breast feeding.
Known intolerance or allergic to eprosartan or sodium nitroprusside.
Blood donation within 1 month of the start of the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erling B Pedersen, MD, professor	Department of Medical Research, Holstebro Hospital	Study Chair

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21640689	Derived	Vase H, Lauridsen TG, Graffe CC, Pedersen EB. The effect of eprosartan on reflex sympathetic activation in sodium restricted patients with essential hypertension. J Am Soc Hypertens. 2011 Sep-Oct;5(5):385-94. doi: 10.1016/j.jash.2011.03.007. Epub 2011 Jun 2.

ID	Term
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases