A Phase IV Clinical Trial of Intensified Blood Pressure Management in Primary Care Using Valsartan Alone and as Combination Anti-Hypertensive Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,337
- 试验地点
- 3
- 主要终点
- Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target
研究概览
简要总结
This study will assess the efficacy of an intensive blood pressure management strategy compared to usual care in a primary care (general practice) setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed or currently treated hypertensive patients who have not attained their blood pressure target and require active pharmacological treatment as recommended by the local guidelines as judged by the general practitioner
排除标准
- •significantly elevated blood pressure (severe hypertension)
- •requiring 3 or more antihypertensive drugs
- •severe kidney disease or dialyses
- •clinical diagnosis requiring concomitant therapy with antihypertensive treatment that would be outside the therapies allowed under study protocol
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Usual care
Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
干预措施: Usual care (Drug)
Monotherapy (initial monotherapy arm)
Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
干预措施: Valsartan and hydrochlorothiazide (HCTZ) - monotherapy (Drug)
Monotherapy (initial monotherapy arm)
Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
干预措施: Valsartan (Drug)
Combination (initial combination therapy arm)
Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
干预措施: Valsartan and amlodipine (Drug)
Combination (initial combination therapy arm)
Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
干预措施: Valsartan and hydrochlorothiazide (HCTZ) - combination arm (Drug)
结局指标
主要结局
Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target
时间窗: 26 weeks
BP target groups were: \<= 125/75mmHg, \<= 130/80mmHg and \<= 140/90mmHg. The BP target was based on the patient's clinical risk profile as specified by National Heart Foundation of Australia guidelines.
次要结局
- Change in Mean Sitting Systolic Blood Pressure(Baseline and 26 weeks)
- Change in Mean Sitting Diastolic Blood Pressure(Baseline and 26 weeks)
- Change in Absolute Cardiovascular Risk Score(Baseline and 26 weeks)
- Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy(26 weeks)
- Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments(26 weeks)
- Change in the EQ-5D Score(Baseline and 26 weeks)
- Number of Patients With Depression(Baseline and week 26)
- Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26(Baseline and week 26)
- Participants With End Organ Disease at Baseline and Week 26(Baseline and week 26)
- Change in Self-care Behavior Score From Baseline to Week 26(Baseline and week 26)
- Rate of Treatment Compliance(26 weeks)
- Number of Patients With Major Clinical Endpoints(26 weeks)