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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. |
Register:
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EUCTR |
Last refreshed on:
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7 September 2021 |
Main ID: |
EUCTR2005-001258-26-ES |
Date of registration:
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23/01/2006 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Extensión de 8 semanas de duración del estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos, de control activo, de 14 semanas de duración para evaluar la efectividad de la estrategia de tratamiento de valsartan con respecto a amlodipino para alcanzar un control de la presión arterial en pacientes con hipertensión grado 1 o grado 2 o no controlada actualmente en monoterapia
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Scientific title:
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Extensión de 8 semanas de duración del estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos, de control activo, de 14 semanas de duración para evaluar la efectividad de la estrategia de tratamiento de valsartan con respecto a amlodipino para alcanzar un control de la presión arterial en pacientes con hipertensión grado 1 o grado 2 o no controlada actualmente en monoterapia |
Date of first enrolment:
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14/03/2006 |
Target sample size:
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224 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001258-26 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Denmark
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Finland
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Germany
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Ireland
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Italy
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Spain
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. MSSBP = 140 mm Hg, and/or MSDBP = 90 mm Hg and currently treated with either valsartan 320 mg/ HCTZ 25 mg or amlodipine 10 mg/ HCTZ 25 mg at Visit C 2. Written informed consent to participate in the extension study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: 1. Premature discontinuation in the core study or failure to comply with the core study protocol 2. Any patient that the investigator decides should not participate in the extension study
Age minimum:
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Essential hypertension
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Intervention(s)
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Product Name: valsartan Pharmaceutical Form: Capsule, hard INN or Proposed INN: valsartan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 160-
Product Name: hydrochlorothiazide Pharmaceutical Form: Capsule, hard INN or Proposed INN: hydrochlorothiazide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25-
Product Name: amlodipine Pharmaceutical Form: Capsule, hard INN or Proposed INN: amlodipine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5-
Product Name: valsartan Pharmaceutical Form: Capsule, hard INN or Proposed INN: valsartan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 320-
Product Name: amlodipine Pharmaceutical Form: Capsule, hard INN or Proposed INN: amlodipine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10-
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Primary Outcome(s)
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Secondary Objective: To evaluate the overall number of patients who reached BP control on the valsartan compared to the amlodipine treatment strategy at end of study including the core and extension phase To evaluate safety and tolerability, measured by rate of adverse events between baseline (Visit C, week 14) and end of study (Visit 8, week 22)
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Main Objective: To assess the incremental rate in blood pressure control for those patients on valsartan 320 mg/HCTZ 25 mg and amlodipine 5/10 mg or amlodipine 10 mg/HCTZ 25 mg and valsartan 160/320 mg at (Visit 7, week 18) and end of study (Visit 8, week 22)
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Primary end point(s): The primary efficacy variable is the proportion of patients who have completed and reached blood pressure control (<140/90 mmHg) at week 22
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Secondary ID(s)
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CVAH631B2406 E1
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 13/02/2006
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