NCT00649389已完成3 期
A Randomized, Double-Blind, Parallel Group Study Evaluating the Efficacy and Safety of Co-Administration of a Triple Combination Therapy of Olmesartan Medoxomil, Amlodipine Besylate and Hydrochlorothiazide in Subjects With Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,500
- 主要终点
- Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP).
研究概览
简要总结
To determine the effectiveness of four different strength combinations of three approved anti-hypertension therapies (olmesartan medoxomil, amlodipine, and hydrochlorothiazide) for lowering blood pressure.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Demonstrable hypertension defined as mean sitting trough cuff blood pressure ≥ 140/100 mmHg (SeSBP ≥ 140 mmHg and SeDBP ≥ 100mmHg) or mean sitting trough cuff BP ≥ 160/90 mmHg (SeSBP ≥ 160 mmHg and SeDBP ≥ 90mmHg).
- •Male or female newly diagnosed hypertensive subjects or currently on hypertension medication.
- •Negative urine pregnancy test at screening
- •Not lactating
- •Do not plan to become pregnant during the study
- •Will practice birth control throughout the study by the following: oral or patch contraceptive, injectable or implantable contraceptive medication, intrauterine device, diaphragm or female condom plus spermicide
- •Non childbearing potential must be classified by one of the following criteria
- •Had a hysterectomy or tubal ligation at least 6 months prior to consent
- •Has been postmenopausal for a least 1 year
排除标准
- •Mean sitting trough cuff DBP <90 mmHg or mean sitting trough cuff SBP <140 mmHg (off antihypertensive medication).
- •Subjects with uncontrolled hypertension taking multiple antihypertensive therapies (at the discretion of the investigator).
- •Signs or symptoms which could exacerbate the occurrence of hypotension such as volume and salt depletion.
- •History of hypertensive encephalopathy, stroke or transient ischemic attack (TIA).
- •Participation in another clinical trial involving an investigational drug within one month prior to screening.
- •History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina within the past 6 months.
- •Any history of New York Heart Association Class III or IV congestive heart failure (CHF). A history of New York Heart Association Class I or II CHF may be exclusionary at the discretion of the investigator.
- •History of secondary hypertension including renal disease, pheochromocytoma, or Cushing's syndrome.
- •Uncorrected coarctation of the aorta, bilateral renal artery stenosis, or unilateral renal artery stenosis in a solitary kidney.
- •Evidence of symptomatic resting bradycardia.
- •Evidence of hemodynamically significant cardiac valvular disease.
- •Presence of heart block greater than first degree atrioventricular block, chronic atrial fibrillation or flutter.
- •Uncontrolled Type I or Type II diabetes defined as HbA1c >9.0%. Diabetics must have documentation of HbA1c within 6 months of the Screening Visit. Undocumented subjects must have their HbA1c assessed prior to randomization. Note: Subjects with Type I or Type II diabetes controlled with insulin, diet or oral hypoglycemic agents on a stable dose for at least 30 days may be included.
- •Evidence of liver disease as indicated by ALT and AST and/or total bilirubin >3 times the upper limit of normal.
- •Severe renal insufficiency defined as a creatinine clearance (based on the Cockcroft-Gault formula) of <30 mL/min.
- •Clinically significant laboratory elevations at Visit 1 that compromise subject safety, based on the investigator's judgment. Consideration should take into account the potential laboratory effects of the component blinded therapies.
- •Positive for any one of the following tests: hepatitis B surface antigen, hepatitis C antibody (confirmed by radio immunobinding assay, RIBA) or HIV antibody (confirmed by western blot assay).
- •Subjects with malignancy during the past 2 years excluding squamous cell or basal cell carcinoma of the skin.
- •Known allergy to any of the medications used in the study.
- •Subjects who require or are taking any concomitant medication, which may interfere with the objectives of the study (Refer to Section 5.2 for a listing of excluded medications).
- •Pregnant or lactating females.
- •Current history of drug or alcohol abuse.
- •A subject with any medical condition, which in the judgment of the Investigator would jeopardize the evaluation of efficacy or safety and/or constitute a significant safety risk to the subject.
研究组 & 干预措施
AML10/HCTZ25
Active Comparator
amlodipine 10mg and hydrochlorothiazide 25mg
干预措施: Amlodipine (Drug)
AML10/HCTZ25
Active Comparator
amlodipine 10mg and hydrochlorothiazide 25mg
干预措施: Hydrochlorothiazide (Drug)
OM40/AML10
Experimental
olmesartan medoxomil 40mg and amlodipine 10mg
干预措施: Olmesartan medoxomil (Drug)
OM40/AML10
Experimental
olmesartan medoxomil 40mg and amlodipine 10mg
干预措施: Amlodipine (Drug)
OM40/HCTZ25
Active Comparator
olmesartan medoxomil 40mg and hydrochlorothiazide 25mg
干预措施: Olmesartan medoxomil (Drug)
OM40/HCTZ25
Active Comparator
olmesartan medoxomil 40mg and hydrochlorothiazide 25mg
干预措施: Hydrochlorothiazide (Drug)
OM40/AML10/HCTZ25
Active Comparator
olmesartan medoxomil 40mg, amlodipine 10mg, and hydrochlorothiazide 25mg
干预措施: Olmesartan medoxomil (Drug)
OM40/AML10/HCTZ25
Active Comparator
olmesartan medoxomil 40mg, amlodipine 10mg, and hydrochlorothiazide 25mg
干预措施: Amlodipine (Drug)
OM40/AML10/HCTZ25
Active Comparator
olmesartan medoxomil 40mg, amlodipine 10mg, and hydrochlorothiazide 25mg
干预措施: Hydrochlorothiazide (Drug)
结局指标
主要结局
Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP).
时间窗: baseline to 12 weeks
次要结局
- Change in Mean 24-hour Ambulatory Blood Pressure From Baseline to Week 12 or Early Termination(Baseline to 12 weeks or early termination)
- Percentage of Subjects Who Reached Blood Pressure Goal (<140/90 mmHg; <130/80 mmHg for Subjects With Diabetes, Chronic Renal Disease, or Chronic Cardiovascular Disease)by 12 Weeks(Baseline to 12 weeks)
- Change in Seated Systolic Blood Pressure From Baseline to Week 12(Baseline to week 12)
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