NCT00095550已完成3 期
The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Patients With Moderate Hypertension
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 496 人开始时间: 2004年10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
- 496
- 试验地点
- 1
- 主要终点
- Change from baseline in SeSBP at Week 8
研究概览
简要总结
The purpose of this clinical research is to learn if moderate 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
- •Willing to provide written informed consent
- •Subjects must have uncontrolled hypertension defined as:
- •average systolic blood pressure between 160 mmHg and 180 mmHg (while diastolic blood pressure is less than 110 mmHg) or
- •average diastolic blood pressure between 100 mmHg and 110 mmHg (while systolic blood pressure is between 130 mmHg and 180 mmHg)
- •Subjects must be willing to discontinue their antihypertensive medication, if applicable.
- •Men and women, ages 18 and older will be included.
- •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 six months.
- •Significant kidney disease
- •Significant liver disease
- •Systemic lupus erythematosus
- •Gastrointestinal disease or surgery that 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)
A3
Active Comparator
干预措施: HCTZ monotherapy (Drug)
结局指标
主要结局
Change from baseline in SeSBP at Week 8
次要结局
- Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 12 weeks of therapy.
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe HypertensionHypertensionNCT00095394Bristol-Myers Squibb645
已完成
4 期
Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive PatientsHypertensionNCT00670566Sanofi503
已完成
4 期
ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide CombinationHypertensionNCT00708344Sanofi832
已完成
4 期
Irbesartan in the Treatment of Hypertensive Patients With Metabolic SyndromeMetabolic SyndromeHypertensionNCT00110422Bristol-Myers Squibb400
进行中（未招募）
不适用
The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First LineTreatment for Severe HypertensioSevere HypertensionEUCTR2004-000020-32-BEBristol Myers Squibb International Corporation826