CLINICAL TRIALS CENTER FOR ALLHAT

ALLHAT 临床试验中心

• 批准号: 6356816
• 负责人: BARRY DAVIS
• 金额: $ 625.9万
• 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/6356816
• 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临床试验 抗高血压药物治疗，以及胆固醇治疗 降压疗法。四万名高血压高危患者，年龄 55 岁及以上的人，包括很大比例的非裔美国人，正在接受治疗 被招募了。因为糖尿病和高血压经常同时发生 糖尿病高血压患者心血管疾病的发病率很高， 招募了很高比例的糖尿病患者。初级 双盲抗高血压试验的目的是确定 非致命性心肌梗死和非致命性心肌梗死的合并发生率是否 接受治疗的患者中冠心病死亡率较低 赖诺普利（ACE 抑制剂）、氨氯地平（钙拮抗剂）或 多沙唑嗪（α-1 阻滞剂）比对照组接受 氯噻酮（利尿剂）。次要终点是心血管总量 死亡率、主要发病率、全因死亡率和健康相关死亡率 生活质量。脂质试验的主要目的是 确定中等程度的全因死亡率是否较低 高胆固醇血症男性女性患者接受胆固醇治疗 降低药物普伐他汀（HMG CoA 还原酶抑制剂），比开放 “常规护理”对照组。次要终点是合并的 非致命性心肌梗塞和冠心病的发病率 死亡、主要非心血管疾病发病率和死亡率以及健康状况 相关的生活质量。平均随访时间将 大约 6 (4.5 - 7.5) 年。 不是使用独立资助的诊所，而是招募患者 通过基于办公室的实践和高血压诊所 通过临床试验中心按每位患者报销。 该合同适用于临床试验中心。部分功能 临床试验中心的职责包括协调所有数据收集， 数据存储、与研究相关的分析活动，以及 招募和培训（与 NHLBI 一起）适当的临床 地点和核心实验室需要进行研究。