NCT04591808终止3 期
Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia, 8 Weeks, Phase 3, Randomized, Double-blind, Active-control, Multinational, Multi-center, Parallel Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 146
- 试验地点
- 43
- 主要终点
- Systolic blood pressure (SBP)
研究概览
简要总结
The purpose of this study is to demonstrate the superiority of atorvastatin/perindopril fixed dose combination (FDC) S05167 as compared to atorvastatin reference drug alone or perindopril drug alone on systolic blood pressure decrease and LDL cholesterol decrease respectively in patients presenting with hypertension and dyslipidemia after 8 weeks of treatment.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women from 18 to 79 years old who can comply with the study requirements and timetable,
- •Patients diagnosed with Essential hypertension (as documented in patient's medical file). The diagnosis of hypertension should be based on at least two BP measurements on at least two visits.
- •Uncontrolled hypertensive patients currently under monotherapy treatment within at least 4 weeks (except patients treated by perindopril) for combined systolic and diastolic hypertension (140 mmHg ≤ SBP < 160 mmHg and 90 mmHg ≤ DBP < 100 mmHg).
- •or Hypertensive patients naïve of treatment with 150 mmHg ≤ SBP <160 mmHg and 90 mmHg ≤ DBP < 100 mmHg.
- •Dysplipidemic patients: naïve of treatment or uncontrolled with statin at lowest dose within at least 4 weeks with 110 mg/ Decilitre (dL) (or 2.84 millimole [mmol] /L) ≤ LDL-c < 190 mg/dL (or 4.91 mmol/L) according to a previous laboratory result within 12 months.
排除标准
- •Unlikely to cooperate in the study,
- •Pregnant and lactating women,
- •Participation in another study at the same time or having participated in another study within 3 months before selection participation in noninterventional registries or epidemiological studies is allowed,
- •6.Patients treated with >1 anti-hypertensive drug or >1 Lipid lowering drug,
- •7.Patients previously treated with atorvastatin and/or perindopril,
- •8.Known resistance to ACE inhibitors,
- •9.Patients treated with beta-blockers or alpha-blockers,
- •Patients with liver disease or renal impairment,
- •11.Certain known cardiovascular diseases or cardiac rhythm disorders,
- •12.Known or suspected symptomatic orthostatic hypotension,
- •13.Familial hypercholesterolemia,
- •14.Secondary hypertension or dyslipidemia,
- •15.Patients who are hypersensitive to atorvastatin, perindopril or to any of the excipients of study drugs,
- •16.Hypersensitivity to any other ACE inhibitor,
- •17.History of angioedema associated with previous ACE inhibitor therapy.
研究组 & 干预措施
Coversyl®
Active Comparator
干预措施: Perindopril (Drug)
S05167
Experimental
干预措施: Atorvastatin/Perindopril (Drug)
Lipitor®
Active Comparator
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Systolic blood pressure (SBP)
时间窗: Over 8 weeks
Mean change from baseline in sitting systolic blood pressure (SBP) in the S05167 group as compared with the Lipitor group (in terms of superiority)
Low-Density Lipoprotein Cholesterol (LDLc)
时间窗: Over 8 weeks
Percent of change from baseline in Low-Density Lipoprotein Cholesterol (LDLc) in the S05167 group as compared with the Coversyl group (in terms of superiority)
次要结局
- Blood pressure response(Over 8 weeks)
- Diastolic blood pressure (DBP)(Over 8 weeks)
- Blood pressure control(Over 8 weeks)
- Systolic blood pressure (SBP)(Over 8 weeks)
- Lipids control(Over 8 weeks)
- Density Lipoprotein Cholesterol (LDLc)(Over 8 weeks)
- Pulse Pressure(Over 8 weeks)
- Lipid parameters(Over 8 weeks)
- Adverse events and Serious adverse events (SAE)(Over 8 weeks)
- Vital signs(Over 8 weeks)
- Electrocardiogram(Over 8 weeks)
- Clinical lab tests(Over 8 weeks)
研究者
研究点 (43)
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