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临床试验/NCT00791258
NCT00791258已完成4 期

A Prospective, Open-Label, Titration Study to Evaluate the Efficacy and Safety Safety of AZOR in Multiple Subgroups of Hypertensive Subjects Who Are Non-Responders to Anti-Hypertensive Monotherapy

Daiichi Sankyo0 个研究点目标入组 999 人开始时间: 2008年11月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
999
主要终点
The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 Weeks
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood pressure reduction using one anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to lower blood pressure in the same patient population. All three medications being tested have been approved by the FDA for the treatment of high blood pressure, but only amlodipine and olmesartan are currently approved for use in combination form.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •>= to 18 years of age
  • •Hypertension uncontrolled on current monotherapy
  • •negative serum pregnancy test at screening
  • •post menopausal or have had a hysterectomy or tubal ligation or practicing approved methods of birth control

排除标准

  • •Pregnant females
  • •Uncontrolled hypertension with multiple drugs, except for hydrochlorothiazide/triamterene
  • •Diabetes requiring insulin
  • •Serious disorders that may limit the ability to evaluate the efficacy or safety of treatment
  • •History of myocardial infarction, bypass graft, angioplasty or heart failure within the past 6 months
  • •History of Class III or IV congestive heart failure
  • •History of stroke or transient ischemic attack within the last 1 year

研究组 & 干预措施

1

Experimental

Azor tablets and hydrochlorothiazide tablets (if necessary) will be administered for up to 20 weeks

干预措施: amlodipine and olmesartan medoxomil tablets (Drug)

1

Experimental

Azor tablets and hydrochlorothiazide tablets (if necessary) will be administered for up to 20 weeks

干预措施: hydrochlorothiazide tablets (Drug)

结局指标

主要结局

The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 Weeks

时间窗: baseline to 12 weeks

次要结局

  • The Percentage of Subjects Achieving Seated Diastolic BP Goal (<90 mmHg for Non-diabetics or < 80 mmHg for Subjects With Diabetes) From Baseline to 12 Weeks(baseline to 12 weeks)
  • The Percentage of Subjects Who Achieve BP Goal (<140/90 mmHg for Non-diabetics or <130/80 mmHg for Diabetics) From Baseline to 12 and 20 Weeks(Baseline to 12 and 20 weeks)
  • Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks(Baseline to 12 weeks)
  • Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks(Baseline to 20 weeks)
  • Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks(Baseline to 12 weeks)
  • Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks(Baseline to 20 weeks)
  • Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks(Baseline to 12 weeks)
  • Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks(Baseline to 20 weeks)
  • Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values(Baseline to 12 weeks)
  • Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values(Baseline to 20 weeks)
  • Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks(Baseline to 4, 8, 12, 16, 20 weeks)
  • Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks(Baseline to 12 weeks)
  • Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks(Baseline to 20 weeks)
  • Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks(Baseline to 12 weeks)
  • Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks(Baseline to 20 weeks)
  • Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks(Baseline to 12 weeks)
  • Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks(Baseline to 20 weeks)
  • Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks(Baseline to 12 weeks)
  • Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks(Baseline to 20 weeks)
  • Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks(Baseline to 12 weeks)
  • Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks(Baseline to 20 weeks)
  • Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks(Baseline to 12 weeks)
  • Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks(Baseline to 20 weeks)

研究者

申办方类型
Industry

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