A 54-week Extension to the Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled, Factorial Study to Evaluate the Efficacy and Safety of VAA489 (Valsartan and Amlodipine Combined) and Alone in Essential Hypertensive Patients - Long Term Study of VAA489 in Patients With Essential Hypertension (Extension From A1301 Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 403
- 试验地点
- 1
- 主要终点
- Safety assessed by serious and non-serious adverse events
研究概览
简要总结
The purpose of this study is to evaluate long-term safety and tolerability of once daily administration of the combination of Valsartan and Amlodipine 80/5 mg for 52 weeks in patients with essential hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who successfully complete the core study (Study CVAA489A
- •Patients whose blood pressure at Visit 7 of the Study CVAA489A1301 had to be well controlled defined as MSDBP < 90 mmHg and MSSBP < 140 mmHg. At the investigator's or sub-investigator's discretion, those patients who were not well controlled (MSDBP ≥ 90 mmHg or MSSBP ≥ 140 mmHg), and whose MSDBP was < 100 mmHg and MSSBP was < 160 mmHg might participate in the extension if this was considered an acceptable level of blood pressure control for the patient.
- •Male or female outpatients.
- •Patients who have written informed consent to participate in this study.
排除标准
- •Presence of major protocol violation in Study CVAA489A
- •Patients who experienced any adverse events considered serious and drug related in Study CVAA489A
- •Patients who experienced any adverse events considered serious and drug related in Study CVAA489A
- •Patients who are considered unlikely to comply with the requirements specified in the protocol by the investigator or sub-investigator.
- •Patients who have gout or gouty arthritis.
- •Patients hypersensitive to diuretics (except for potassium sparing diuretics).
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Valsartan + Amlodipine 80/5 mg
Valsartan 80 mg or Amlodipine 5 mg ---> Valsartan + Amlodipine 80 / 5 mg
干预措施: Valsartan + Amlodipine besilate (Drug)
Valsartan + Amlodipine 80/5 mg + Diuretic
Valsartan + Amlodipine 80 / 5 mg + Diuretic
干预措施: Valsartan + Amlodipine besilate (Drug)
结局指标
主要结局
Safety assessed by serious and non-serious adverse events
时间窗: 12 months
No new unexpected AE's were observed in long-term treatment with VAA 80/5 mg. There were no deaths during the study. The SAEs were rare, with 9 patients (2.5%) reporting 10 events (1 patient experienced 2 SAEs). These events were not clustered to any particular primary system organ class and only 2 events the investigators could not excluded a relationship to study drug. The events that occurred were expected in this study population and/or were known to be associated with either valsartan or amlodipine. AEs leading to discontinuation occurred in 14 patients (3.8%).
次要结局
- Efficacy assessed by the changes-from baseline measurements in mean sitting diastolic blood pressure, mean sitting systolic blood pressure, standing diastolic blood pressure, and standing systolic blood pressure(12 months)
- Laboratory tests(12 months)
- Vital signs(12 months)
- Electrocardiogram (ECG)(12 months)