A Multiple-Dose Clinical Trial to Study the Effect of MK-8457 on Ambulatory Blood Pressure in Hypertensive Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experienced at Least One Adverse Event (AE)
研究概览
简要总结
This study will evaluate the effect of treatment with multiple doses of MK-8457 on systolic blood pressure in participants with mild to moderate hypertension in addition to safety and tolerability. The study hypothesis is that MK-8457 does not increase systolic blood pressure to a clinically significant extent, as measured by 24-hour mean ambulatory systolic blood pressure change from baseline after 10 days of dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •If female, must be of non-childbearing potential
- •If male with female partner(s) of child-bearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug
- •Body mass index (BMI) ≤35 kg/m^2
- •Mild-to-moderate hypertension requiring treatment with one or more antihypertensive agents
- •Receiving stable treatment for hypertension for at least 8 weeks prior to the start of dosing and continuing therapy for duration of study
- •No clinically significant arrhythmias or clinically significant abnormality on electrocardiogram
- •Nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
排除标准
- •Any illness that might confound the results of the study or poses an additional risk
- •History of stroke, chronic seizures, or major neurological disorder
- •Clinically significant endocrine, gastrointestinal, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- •Clinically significant cardiovascular disease or has active angina
- •History of malignant neoplastic disease
- •Taking 325 mg aspirin daily
- •Taking 3 or more medications for the treatment of hypertension
- •Unable to refrain from or anticipates the use of any non-steroidal anti-inflammatory drugs (NSAIDs)
- •Consumes excessive amounts of alcohol and/or coffee, tea, cola, or other caffeinated beverages
- •Has had major surgery, donated or lost 1 unit of blood or participated in another investigational study within 4 weeks
- •Significant multiple and/or severe allergies
- •Regular user of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 2 years
研究组 & 干预措施
MK-8457-Placebo Sequence
Participants received MK-8457 100 mg twice daily (BID) for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
干预措施: MK-8457 (Drug)
MK-8457-Placebo Sequence
Participants received MK-8457 100 mg twice daily (BID) for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.
干预措施: Placebo for MK-8457 (Drug)
Placebo-MK-8457 Sequence
Participants received Placebo for 10 days followed by MK-8457 100 mg BID for 10 days. Each treatment was separated by a 10-day washout.
干预措施: MK-8457 (Drug)
Placebo-MK-8457 Sequence
Participants received Placebo for 10 days followed by MK-8457 100 mg BID for 10 days. Each treatment was separated by a 10-day washout.
干预措施: Placebo for MK-8457 (Drug)
结局指标
主要结局
Number of Participants Who Experienced at Least One Adverse Event (AE)
时间窗: Up to 70 days
An AE is defined as any unfavorable and unintended medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Number of Participants Who Discontinued the Study Medication Due to an AE
时间窗: Up to 70 days
An AE is defined as any unfavorable and unintended medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Change From Baseline to Day 10 in 24-hour Mean Ambulatory Systolic Blood Pressure (SBP)
时间窗: Baseline and Day 10
SBP was measured using ambulatory blood pressure monitoring (ABPM) on Day -1 and Day 10 of each treatment period. The 24-hour least squares (LS) mean ambulatory SBP change from baseline was then determined for Day 10, the last day of multiple dose treatment. Baseline is defined as the average 24-hour SBP for each participant on Day -1. Increased values represent an increase in hypertensive severity.
次要结局
- Change From Baseline to Day 10 in 24-hour Mean Ambulatory Diastolic Blood Pressure (DBP)(Baseline and Day 10)
- Change From Baseline to Day 10 in Maximum Moving Average (maxMAΔ) Blood Pressure Measured Over 4 Hours(Up to 4 hours postdose on Days 1 and 10)
- Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours (AUC0-12hr) of MK-8457(pre-AM dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post AM dose on Days 1 and 10)
- Maximum Concentration (Cmax) of MK-8457(pre-AM dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post AM dose on Days 1 and 10; 24 hrs post-AM dose on Day 10)
- Time to Maximum Concentration (Tmax) of MK-8457(pre-AM dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post AM dose on Days 1 and 10; 24 hrs post-AM dose on Day 10)
- Trough Plasma Concentration (Ctrough) of MK-8457(pre-AM dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post AM dose on Days 1 and 10; pre-AM dose on Day 5 or 6)