CLINICAL TRIALS CENTER FOR ALLHAT

ALLHAT 临床试验中心

• 批准号: 6357897
• 负责人: BARRY DAVIS
• 金额: --
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 1993
• 资助国家: 美国
• 起止时间: 1993-08-02 至 2003-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6357897
• 关键词: ACE inhibitors; HMG coA reductases; alpha antiadrenergic agent; amlodipine; antihypercholesterolemic agent; antihypertensive agents; calcium channel blockers; cardiovascular disorder chemotherapy; cardiovascular disorder prevention; chemoprevention; clinical research; clinical trials; comorbidity; coronary disorder; diabetes mellitus; diuretics; gender difference; human middle age (35-64); human mortality; human old age (65+); human subject; human therapy evaluation; hypertension; longitudinal human study; myocardial infarction; quality of life; racial /ethnic difference

ALLHAT is a practice-based, randomized clinical trial of antihypertensive pharmacologic treatment and, in a subset, cholesterol- lowering therapy. Forty thousand high-risk hypertensive patients, age 55 and older, including a high percentage of African-Americans are being recruited. Because diabetes and hypertension occur together frequently and diabetic hypertensives have high rates of cardiovascular disease, a high percentage of diabetic patients were recruited. The primary objective of the double-blind antihypertensive trial is to determine whether the combined incidence of nonfatal myocardial infarction and coronary heart disease death is lower among patients receiving lisinopril (ACE inhibitor), amlodipine (calcium antagonist), or doxazosin (alpha-1-blocker) than in a control group receiving chlorthalidone (diuretic). Secondary endpoints are total cardiovascular mortality, major morbidity, all-cause mortality and health-related quality of life. The primary objective of the lipid trial is to determine whether all-cause mortality is lower in moderately hypercholesterolemic men women patients receiving the cholesterol- lowering drug pravastatin (HMG CoA reductase inhibitor), than in an open "usual care" control group. Secondary endpoints are the combined incidence of nonfatal myocardial infarction and coronary heart disease death, major non-cardiovascular morbidity and mortality, and health- related quality of life. The average duration of follow-up will approximately 6 (4.5 - 7.5) years. Rather than using independently funded clinics, patients are recruited through office-based practices and hypertension clinics which are reimbursed through the Clinical Trials Center on a per-patient basis. This contract is for the Clinical Trials Center. Some of the functions of the Clinical Trials Center include coordinating all data collection, storage of data, analysis activities related to the study, and recruiting and training (along with the NHLBI) appropriate clinical sites and core laboratories require to conduct the study.

Allhat是一项基于实践的，随机的临床试验 降压药物治疗，在子集中胆固醇 - 降低治疗。四万高风险高血压患者，年龄 55岁及以上，包括高百分比的非洲裔美国人 招募。因为糖尿病和高血压经常出现 和糖尿病性高血压患者的心血管疾病率很高， 招募了很大比例的糖尿病患者。主要 双盲降压试验的目的是确定 非致命性心肌梗塞的综合发生率和 接受的冠心病死亡较低 Lisinopril（ACE抑制剂），氨氯地平（钙拮抗剂）或 多沙唑嗪（alpha-1阻滞剂）比接收的对照组 氯丁酮（利尿剂）。次要终点是总心血管 死亡率，主要发病率，全因死亡率和与健康有关 生活质量。脂质试验的主要目的是 确定全因死亡率是否适中较低 高胆固醇的男性患者接受胆固醇的患者 降低药物pravastatin（HMG COA还原酶抑制剂），而不是开放 “通常护理”对照组。次要终点是组合 非致命心肌梗塞和冠状动脉疾病的发生率 死亡，主要的非心血管发病率和死亡率以及健康 - 相关的生活质量。随访的平均持续时间将 大约6（4.5-7.5）年。 招募患者，而不是使用独立资助的诊所 通过基于办公室的实践和高血压诊所 以每个患者的身份通过临床试验中心报销。 该合同适用于临床试验中心。一些功能 临床试验中心包括协调所有数据收集， 数据的存储，与研究相关的分析活动以及 招募和培训（以及NHLBI）适当的临床 站点和核心实验室需要进行研究。