NCT00095394已完成3 期
The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Severe Hypertension
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 645 人开始时间: 2004年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 645
- 试验地点
- 1
- 主要终点
- Proportion of subjects whose seated diastolic blood pressure is controlled (SeDBP < 90 mmHg) at Week 5
研究概览
简要总结
The purpose of this clinical research is to learn if severe hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ages 18 and older;
- •Willing to provide written informed consent;
- •Must have uncontrolled hypertension defined as: currently untreated with a diastolic blood pressure greater than 110 mmHg OR currently receiving antihypertensive monotherapy with a diastolic blood pressure greater than 100 mmHg. Monotherapy is defined as treatment with one antihypertensive medication for at least four weeks; fixed combination therapy does not represent monotherapy;
- •Must be willing to discontinue antihypertensive medication, if applicable;
- •Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to one week after the study in such a manner that the risk of pregnancy is minimized.
- •WOCBP must have a negative serum or urine pregnancy test within 72 hours prior to the start of study medication.
排除标准
- •Women who are pregnant or breastfeeding;
- •Known or suspected secondary hypertension;
- •Hypertension emergencies or stroke within the past 12 months;
- •Heart attack, angina or bypass surgery within the past 6 months;
- •Significant kidney disease;
- •Significant liver disease;
- •Systemic lupus erythematosus;
- •Gastrointestinal disease or surgery that may interfere with drug absorption;
- •Cancer during the past five years excluding localized squamous cell or basal cell carcinoma of the skin;
- •Currently pregnant or lactating;
- •Mental condition (psychiatric or organic cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the study;
- •Drug or alcohol abuse within the last five years;
- •Known allergy to irbesartan or diuretics.
研究组 & 干预措施
A1
Experimental
干预措施: Irbesartan/HCTZ (Drug)
A2
Active Comparator
干预措施: Irbesartan monotherapy (Drug)
结局指标
主要结局
Proportion of subjects whose seated diastolic blood pressure is controlled (SeDBP < 90 mmHg) at Week 5
次要结局
- Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 17 weeks of therapy.
研究者
研究点 (1)
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The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First LineTreatment for Severe HypertensioSevere HypertensionEUCTR2004-000020-32-BEBristol Myers Squibb International Corporation826