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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01214746 |
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Date of registration:
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18/05/2010 |
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Primary sponsor: |
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Public title:
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The Effects of Atorvastatin on the Nitric Oxide-system in Healthy Young Man
STAR |
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Scientific title:
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The Effects of Atorvastatin on the Nitric Oxide-system in Healthy Young Man |
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Date of first enrolment:
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May 2010 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01214746 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Frank H Christensen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medicinsk Forskning |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Men and women, age 18-40 years
- Body Mass Index (BMI) 18,5-30 kg/m2
Exclusion Criteria:
- Arterial hypertension (>140 mmHg systolic and/or 90 mmHg diastolic)
- Anamnestic or clinical signs of heart, lung, lever, kidney and brain disease
- Neoplastic disease
- Alcohol abuse,
- Drug abuse
- Medical treatment except oral anticontraceptive
- Smoking
- Pregnancy or
- Abnormal blood and urine sample
- Abnormal ECG
- Blood donation within a month before examination
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cardiovascular Diseases
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Nephropathy
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Intervention(s)
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Drug: Atorvastatin
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Drug: Placebo
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Primary Outcome(s)
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Fractional excretion of sodium
[Time Frame: 5 days treatment]
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Secondary Outcome(s)
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Augmentation index (AI)
[Time Frame: 5 days]
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Diastolic blood pressure
[Time Frame: 5 days]
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Plasma aldosterone concentration
[Time Frame: 5 days]
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Plasma and urinary albumin concentration
[Time Frame: 5 days]
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plasma atrial natriuretic peptide concentration
[Time Frame: 5 days]
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Plasma brain natriuretic peptide concentration
[Time Frame: 5 days]
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plasma renin concentration
[Time Frame: 5 days]
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Pulse wave velocity
[Time Frame: 5 days]
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Systolic blood pressure (SBP)
[Time Frame: 5 days]
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Urinary excretion of aquaporin-2
[Time Frame: 5 days]
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Urinary excretion of protein from sodium channels such as the NaCl cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel (ENaC)
[Time Frame: 5 days]
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Secondary ID(s)
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EBP-FHC-2010-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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