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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: |
NCT00429897 |
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Date of registration:
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31/01/2007 |
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Primary sponsor: |
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Public title:
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Double Blind Crossover Comparison of Diuretics in the Young
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Scientific title:
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Double Blind Crossover Comparison od Diuretics in Young Patients With Low Renin Hypertension |
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Date of first enrolment:
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August 2006 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00429897 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Morris J Brown, Proffessor |
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Address:
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Telephone:
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01223 336743 |
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Email:
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mjb14@medschl.cam.uk |
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Affiliation:
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Name:
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Morris J Brown, Professor |
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Address:
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Telephone:
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01223 336743 |
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Email:
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mjb14@medschl.cam.ac.uk |
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Affiliation:
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Name:
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Morris J Brown, Proffessor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cambridge University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Aged 18-45
- male or female
- Hypertensive - 3 clinic SBP >=140mmHg; or 3 clinic DBP >=90mmHg; or ABPM or home BP
>=130(SBP) or 85(DBP)
- 24hr Na+<160mmol/l
- EITHER {Plasma renin<=10mU/L (measured untreated, or whilst receiving only
CCB+/-diuretic} + {Plasma renin <=40mU/L (measured on an ACEi or ARB, which
approximately double s the plasma renin)} OR Plasma renin <5mU/L (measured untreated,
or receiving any antihypertensive drug other than a beta-blocker
Exclusion Criteria:
- Documented history of gout
- Abnormal renal function (both elevated serum creatinine and reduced creatinine
clearance
- SBP > 170mmHg or Diastolic >110mmHg despite treatment with permitted background
treatment
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Low-Renin Hypertension
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Intervention(s)
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Drug: Amiloride 20-40mg
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Drug: Bendroflumethiazide 1.25-2.5mg/ Amiloride 10-20mg combined
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Drug: Bendroflumethiazide 2.5mg - 5mg
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Drug: Frusemide 20-40mg
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Drug: Spironolactone 50-100mg
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Primary Outcome(s)
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Difference in plasma renin for subjects' best drug and second best drug.
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Difference in systolic blood pressure for subjects' best drug and second best drug.
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Secondary Outcome(s)
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Predictions of best drug
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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