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Main
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Note: This record shows only 22 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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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN02311110 |
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Date of registration:
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26/07/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Management of patients with uncontrolled arterial hypertension - the role of electronic compliance monitoring, 24 hour ambulatory blood pressure monitoring and candesartan/hydrochlorothiazide (HCTZ)
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Scientific title:
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Date of first enrolment:
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02/01/2001 |
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Target sample size:
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62 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN02311110 |
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Study type:
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Interventional |
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Study design:
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Single-centre randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Thomas
Mengden |
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Address:
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Wilhelmstr 35-37
53111
Bonn
Germany |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with essential hypertension and office Blood Pressure (oBP) more than or equal to 140/90 mmHg, despite combination therapy (more than two antihypertensive drugs)
Exclusion criteria: 1. Pregnancy
2. Known intolerance of HCTZ or Angiotensin II Type One Receptor Blockers (AT1-Blockers)
3. Secondary hypertension
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Resistant arterial hypertension
Circulatory System
Hypertension
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Intervention(s)
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Patients with oBP of more than 140/90 mmHg despite combination therapy were begun on microelectromechanical systems (MEMS) monitoring and self BP measurement for four weeks of run-in.
Of 62 such patients, 18 (29%) were normotensive according to self BP measurement and ambulatory BP measurement at four weeks (Group A); in the remaining 44 still uncontrolled patients, candesartan/HCTZ was substituted for one of the combination therapy drugs, with half these patients receiving passive compliance monitoring (Group B) and the other half in the Drug Regimen Compliance (DRC) intervention program (Group C).
All groups were then followed for eight weeks.
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Primary Outcome(s)
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1. Drug compliance
2. Blood pressure
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Secondary Outcome(s)
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Not provided at time of registration
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Source(s) of Monetary Support
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Astra Zeneca (Germany)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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