NCT00374855已完成2 期
Protocol H8D-MC-EMBH PPAR Alpha (LY518674): a Phase 2 Dose-Response Study to Evaluate the Blood Pressure-Lowering Effect in Essential Hypertension
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 11
- 主要终点
- To test the hypothesis that LY518674, administered for 6 weeks to patients with mild hypertension, reduces 24-hour mean ambulatory Systolic Blood Pressure, compared with placebo.
研究概览
简要总结
The primary objective of this study is to test the hypothesis that LY518674, administered for 6 weeks to patients with mild hypertension, reduces Systolic Blood Pressure, compared with placebo.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are men and women between 18 and 70 years of age, inclusive
- •Have given signed informed consent to participate in this study
- •Are diagnosed with mild essential hypertension at screening (currently untreated or treated with monotherapy)
排除标准
- •Secondary or malignant hypertension
- •Have or have had a history of hyperlipidemia within 3 months of screening requiring treatment
- •Any previous cardiovascular disease other than hypertension
- •Type 1 or 2 diabetes
结局指标
主要结局
To test the hypothesis that LY518674, administered for 6 weeks to patients with mild hypertension, reduces 24-hour mean ambulatory Systolic Blood Pressure, compared with placebo.
次要结局
- Determine the duration and consistency of the reduction in BP over the course of a day, relative to placebo, after 6 weeks of treatment with LY518674 when taken once daily
- Evaluate the population dose and exposure response relationships of LY518674 for lowering the mean SBP and DBP during the 24 hour period, using ABPM during a 6 week treatment period
- Evaluate the population dose, exposure, and time response relationships of LY518674 for lowering the mean SBP and DBP during the 8 hour awake period, using ABPM during a 6 week treatment and following cessation of dosing
- Compare the effect of LY518674 on CBPM SBP and DBP with that of placebo
- Determine the percentage of responders to LY518674, relative to placebo, as defined by patients who achieve target BP goals of CBPM SBP <140 mm Hg and/or DBP 90 mm Hg, or a CBPM SBP decrease of at least 10 mm Hg
- Evaluate the effects of LY518674, relative to placebo, on plasma levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), HDL-C, triglycerides (TG), and high-sensitivity C-reactive protein (hsCRP)
- Evaluate the safety and tolerability effects of LY518674, relative to placebo, in patients with mild hypertension
研究者
研究点 (11)
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