The Effect of Eprosartan on Hormones and Kidney Function in Patients With Essential Hypertension
This study has been completed.
Sponsor:
Regional Hospital Holstebro
Information provided by:
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT00438945
First received: February 20, 2007
Last updated: May 5, 2008
Last verified: May 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Essential Hypertension |
Drug: Eprosartan |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind |
| Official Title: | 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. |
Resource links provided by NLM:
MedlinePlus related topics:
High Blood Pressure
Drug Information available for:
Eprosartan mesylate
U.S. FDA Resources
Further study details as provided by Regional Hospital Holstebro:
Primary Outcome Measures:
- Heart rate
- Fractional sodium excretion
- Plasma levels of noradrenaline
Secondary Outcome Measures:
- Fractional lithium excretion
- Glomerular filtration rate
- plasma levels of renin, angiotensin II, aldosterone, vasopressin, atrial natriuretic peptide and brain natriuretic peptide
- free water clearance
- urinary excretion of aquaporin 2
| Estimated Enrollment: | 18 |
| Study Start Date: | January 2007 |
| Study Completion Date: | January 2008 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438945
Locations
| Denmark | |
| Department of Medical Research, Holstebro Hospital | |
| Holstebro, Denmark, 7500 | |
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
| Study Chair: | Erling B Pedersen, MD, professor | Department of Medical Research, Holstebro Hospital |
More Information
No publications provided by Regional Hospital Holstebro
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Erling Bjerregaard Pedersen, Department of Medical Research, Holstebro Hospital |
| ClinicalTrials.gov Identifier: | NCT00438945 History of Changes |
| Other Study ID Numbers: | MED.RES.HOS.2006.03.HV |
| Study First Received: | February 20, 2007 |
| Last Updated: | May 5, 2008 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: Danish Medicines Agency Denmark: Ethics Committee |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Eprosartan Antihypertensive Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Angiotensin II Type 2 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013