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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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19 March 2012 |
Main ID: |
EUCTR2006-005408-14-BE |
Date of registration:
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15/02/2007 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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An extension to study protocol CVAL489K2302 to evaluate the long term safety, tolerability and efficacy of valsartan children 6 to 17 years of age with hypertension, versus enalapril treatment for 14 weeks, or combined with enalapril for 66 weeks in chronic kidney disease patients.
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Scientific title:
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An extension to study protocol CVAL489K2302 to evaluate the long term safety, tolerability and efficacy of valsartan children 6 to 17 years of age with hypertension, versus enalapril treatment for 14 weeks, or combined with enalapril for 66 weeks in chronic kidney disease patients. |
Date of first enrolment:
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23/04/2007 |
Target sample size:
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270 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-005408-14 |
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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Countries of recruitment
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Belgium
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Czech Republic
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France
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Germany
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Hungary
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Italy
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Sweden
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria: Please refer to CVAL489K2302 for complete details related to the inclusion and exclusion criteria for the core study.
Additional inclusion criteria: - Successful completion of 12 weeks of double blind treatment in core protocol CVAL489K2302 - Discontinueing prematurely from teh core CVAL489K2302 study due to uncontrolled hypertension defined as; MSSBP>20%, but ><25% above the 95th percentile for age, gender, and height after visit 5, qualifies a patient for entry into this extension study. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: Please refer to CVAL489K2302 for complete details related to the inclusion and exclusion criteria for the core study.
Additional exclusion criteria:- - Patients who experienced any adverse events considered serious and drug related in protocol CVAL489K2302 are exluded. - Patients who live far from a site & have logistic difficulties in getting repeat serum potassium test performed whitin 1 week of first elevated values (K+> 5.3) will not be considered for enrollment in the study.
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Trade Name: Diovan 80mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Valsartan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Trade Name: Diovan 160mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Valsartan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 160- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Trade Name: Diovan 320mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Valsartan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 320- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Trade Name: Olinapril 10 mg Product Name: Enalapril Pharmaceutical Form: Tablet Other descriptive name: Enalapril Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Trade Name: Olinapril 20 mg Product Name: Enalapril Pharmaceutical Form: Tablet Other descriptive name: Enalapril Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: For full list, please refer to protocol. To evaluate :- - The % of non-CKD patients treated with valsartan or enalapril alone with a MSSBP >95th percentile for gender, age and height from baseline to week 26 (responder) - the MSSBP reduction in non-CKD patients treated with valsartan or enalapril alone from baseline to week 26 (BP reduction) - The % of non-CKD patients treated with valsartan or enalapril alone from baseline to week 26 (BP reduction).
Exploratory objectives: To evaluate: - The % of CKD patients treated with valsartan & enalapril combination vs. enalapril monotherapy achieving urine protien/cratinine ratio (UPCR) reduction by = 25% from week 12 - week 78 - the % of CKD patients on valsartan and enalapril combination vs. enalapril monotherapy with a MSSBP < 90th percentile for gender, age and height at week 78.
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Primary end point(s): The primary objective of this extension study is to assess the safety and tolerability of valsartan and enalapril, alone or in combination, from the start of the core study through the end of the extension study. The safety data during the 78 week period for the extension safety patients will be used as the bais of this assessment.
The assessment of safety will be based mainly on the frequency of adverse events and on the summary of laboratory values. Other safety data (e.g., pulse, standing blood pressures, body weight) will be summarized as appropriate.
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Main Objective: To assess the long-term safety and tolerability of valsartan and enalapril alone or in combination in children aged 6-17 years with hypertension.
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Secondary ID(s)
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CVAL489K2302-E1
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Source(s) of Monetary Support
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Results
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Results available:
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Date Completed:
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