ANTIHYPERTENSIVE ACTIVITY OF SR49059 IN HYPERTENSION IN TWO ETHNICITIES

SR49059 在两个种族高血压中的抗高血压活性

• 批准号: 6246433
• 负责人: MARC THIBONNIER
• 金额: $ 1.98万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-01-06 至 1997-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6246433
• 关键词: African American; antihypertensive agents; blood pressure; cardiovascular disorder chemotherapy; caucasian American; clinical research; clinical trials; dosage; drug screening /evaluation; human subject; human therapy evaluation; hypertension; oral administration; racial /ethnic difference; saline

The objective of this study is to assess the blood pressure lowering effect of a single 300 mg oral dose of SR 49059 in African American and Caucasian hypertensive patients before, during, and after a hypertonic saline infusion. Based on pharmacology and both acute toxicology (LDO>2g/kg) and the 4-week repeated administration studies, and on preliminary safety data from the first single ascending oral dose tolerability trial, a minimal effective dose of 300 mg of SR 49059 is considered to be safe to be administered to humans. Twenty-four subjects completed the study and data is in analysis.

本研究的目的是评估血压降低效果 单次 300 mg 口服剂量 SR 49059 对非裔美国人和 高加索高血压患者在高渗之前、期间和之后 输注生理盐水。 基于药理学和急性毒理学 (LDO>2g/kg)和4周重复给药研究，以及 首次单次递增口服剂量的初步安全性数据 耐受性试验，SR 49059 的最小有效剂量为 300 mg 被认为对人类施用是安全的。二十四科 已完成研究，数据正在分析中。