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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-005408-14-HU
• Date of registration: 26/03/2007
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• 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
• 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
• Date of first enrolment: 14/05/2007
• Target sample size: 270
• 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 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.



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

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

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: CPO to complete
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: CPO to complete
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

Primary Outcome(s)

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.

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, during the 26 week of treatment from the start of the core study through the end of the extension study. The safety data during the 26 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.

Secondary Objective: For full list, please refer to protocol.
To 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)
- the percentage of non-CKD patients treated with valsartan or enalapril alone with
a MSDBP >95th percentale 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)

Exploratory objectives:
To evaluate:
- The percentage of CKD patients treated with valsartan and enalapril combination
or enalapril monotherapy achieving urine protien/cratinine ratio (UPCR) reduction
by = 25% from week 12 to week 26
- the percentage of CKD patients on valsartan and enalapril combination vs.
enalapril monotherapy who have urine prtein/creatinine ratio (UPCR) reduced by =
50% from baseline to week 26.

Secondary ID(s)

2006-005408-14-BE

CVAL489K2302-E1