Hypertension
Conditions
Interventions
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 fo
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion 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 >=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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. ;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. | — |
Countries
Belgium, Czech Republic, France, Germany, Hungary, Italy, Sweden, United Kingdom
Outcome results
None listed