EUCTR2006-005408-14-IT进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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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 hypertensioMedDRA version: 9.1Level: LLTClassification code 10020772Term: HypertensionHypertensionEUCTR2006-005408-14-FRovartis Pharma Services AG250