EFFICACY AND SAFETY OF MIBEFRADIL IN HYPERTENSION VERSUS LOSARTAN

米贝拉地尔与氯沙坦治疗高血压的疗效和安全性

• 批准号: 6113543
• 负责人: ALAN B WEDER
• 金额: $ 0.02万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6113543
• 关键词: calcium channel blockers; cardiovascular disorder chemotherapy; clinical research; dosage; drug screening /evaluation; human subject; human therapy evaluation; hypertension; losartan; vasodilators

The objective of the current study is to evaluate the differnce between mibefradil and losartan in the change of mean trough sitting diastolic blood pressure (SDBP) measurements after 8 weeks of active treatment. This study includes a 4-week placebo run-in period followed by an 8-week treatment period. During the first 4 weeks of the treatment period, the patients receive either mibefadil (50mg), or losartan(50mg). At week 4, patients responding to the study drug, mean trough SDBP<90mmHg, will continue on the same study drug at the same dose for four more weeks. Patients with mean trough SDBP>90mm Hg, will titrate up to a final dose of 100 mg once daily for the remaining 4 weeks through weeek 8.

本研究的目的是评价米贝拉地尔和氯沙坦在积极治疗8周后平均坐位舒张压(SDBP)的变化。这项研究包括4周的安慰剂磨合期和8周的治疗期。在疗程的前4周，患者接受米贝法地尔(50 Mg)或氯沙坦(50 Mg)治疗。在第4周，对研究药物有反应的患者将继续以相同的剂量继续服用相同的研究药物4周。平均滴定值为90毫米汞柱的患者，在接下来的4周内每天滴定最多100毫克，直到第8周。