- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00438945
The Effect of Eprosartan on Hormones and Kidney Function in Patients With Essential Hypertension
May 5, 2008 updated by: Regional Hospital Holstebro
The Effect of Eprosartan in Patients With Essential Hypertension on Renal Tubular Function and Vasoactive Hormones During Baseline Conditions and After Activation of the Sympathetic Nervous System.
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
18
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Holstebro, Denmark, 7500
- Department of Medical Research, Holstebro Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Fractional sodium excretion
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Heart rate
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Plasma levels of noradrenaline
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Secondary Outcome Measures
Outcome Measure |
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Glomerular filtration rate
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Fractional lithium excretion
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plasma levels of renin, angiotensin II, aldosterone, vasopressin, atrial natriuretic peptide and brain natriuretic peptide
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free water clearance
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urinary excretion of aquaporin 2
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Erling B Pedersen, MD, professor, Department of Medical Research, Holstebro Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
February 20, 2007
First Submitted That Met QC Criteria
February 21, 2007
First Posted (Estimate)
February 22, 2007
Study Record Updates
Last Update Posted (Estimate)
May 9, 2008
Last Update Submitted That Met QC Criteria
May 5, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MED.RES.HOS.2006.03.HV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Essential Hypertension
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Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
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Addpharma Inc.Completed
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Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
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Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
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BayerCompletedHypertension, EssentialGermany
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National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
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Addpharma Inc.Not yet recruitingHypertension,Essential
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Instituto de Cardiologia do Rio Grande do SulRecruitingHypertension | Hypertension,EssentialBrazil
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Federal University of Health Science of Porto AlegreIrmandade Santa Casa de Misericórdia de Porto Alegre; Leonhardt Ventures LLCNot yet recruitingHypertension | Hypertension,Essential
Clinical Trials on Eprosartan
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AbbottQuintiles, Inc.; Synexus; author! et al. BVCompletedEssential HypertensionGermany, Russian Federation, United Kingdom
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Solvay PharmaceuticalsCompletedHypertension | Type 2 DiabetesFrance, Canada, Denmark, Germany, Italy, Norway, Spain, Sweden, United Kingdom
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Medical University of LodzCompletedUric Acid Concentration, Serum, Quantitative Trait Locus 7
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Regional Hospital HolstebroCompleted
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Eunice Kennedy Shriver National Institute of Child...CompletedHealthy | Cushing's Syndrome | Adrenal Gland Hyperfunction | Adrenal Gland HypofunctionUnited States
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Brigham and Women's HospitalActive, not recruitingFrailty | Heart Failure, SystolicUnited States
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University of British ColumbiaCanadian Institutes of Health Research (CIHR)TerminatedCovid19 | SARS-CoV InfectionCanada, France
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The George InstituteCompletedCOVID-19 | Coronavirus Disease 2019Australia, India
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National University of Ireland, Galway, IrelandSuspended
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University of California, San FranciscoCompletedKidney DiseaseUnited States