A 14 week extension to a randomized, double-blind, multicenter, parallel-group, active-controlled study to evaluate the long term safety, tolerability and efficacy of valsartan and enalapril combined and alone in children 6 to 17 years of age with hypertension - ND

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-005408-14-IT
• Date of registration: 29/08/2007
• Prospective Registration: No
• Primary sponsor: NOVARTIS FARMA
• Public title: A 14 week extension to a randomized, double-blind, multicenter, parallel-group, active-controlled study to evaluate the long term safety, tolerability and efficacy of valsartan and enalapril combined and alone in children 6 to 17 years of age with hypertension - ND
• Scientific title: A 14 week extension to a randomized, double-blind, multicenter, parallel-group, active-controlled study to evaluate the long term safety, tolerability and efficacy of valsartan and enalapril combined and alone in children 6 to 17 years of age with hypertension - ND
• Date of first enrolment: 12/06/2007
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-005408-14
• Study type: Interventional clinical trial of medicinal product
• Study design: 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

Countries of recruitment

Belgium, Czech Republic, France, Germany, Hungary, Italy, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Please refer to the 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. Discontinuing prematurely from the 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 the 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 excluded.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

hypertension
MedDRA version: 9.1 Level: LLT Classification code 10020772 Term: Hypertension

Intervention(s)

Product Name: valsartan
Product Code: VAL489K
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

Product Name: valsartan
Product Code: VAL489K
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

Product Name: valsartan
Product Code: VAL489K
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: ENALAPRIL DOC
Pharmaceutical Form: Tablet
INN or Proposed INN: 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: ENALAPRIL DOC
Pharmaceutical Form: Tablet
INN or Proposed INN: Enalapril
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: ENALAPRIL DOC
Pharmaceutical Form: Tablet
INN or Proposed INN: 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

Primary Outcome(s)

Secondary Objective: Evaluate the percentage 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). Evaluate the percentage of non-CKD patients treated with valsartan or enalapril alone with a MSDBP < 95th percentile for gender, age and height from baseline to week 26 (responder). Evaluate the MSSBP reduction in non-CKD patients treated with valsartan or enalapril alone from baseline to week 26 (BP reduction). Evaluate the MSDBP reduction in non-CKD patients treated with valsartan or enalapril alone from baseline to week 26 (BP reduction). Evaluate the safety and tolerability of valsartan and enalapril combination compared to enalapril monotherapy from week 12 to week 26 Evaluate the mean ambulatory blood pressure reduction for all patients (participating in ABPM) from baseline to week 26 as measured by 24 hour ABPM.

Main Objective: To assess the long-term safety and tolerability of valsartan and enalapril alone or in combination in children aged 6-17 years old with hypertension.

Primary end point(s): The extension endpoint is defined as the Week 26 value, or the last observation after the core endpoint carried forward (LOCF) for patients missing the Week 26 value.

Secondary ID(s)

2006-005408-14-BE

CVAL489K2302E1