NCT00263003已完成3 期
A Randomized, Open Label Comparative Study of Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Compare the reduction in office BP following a 8-week regimen of irbesartan / hydrochlorothiazide versus irbesartan
研究概览
简要总结
Study Objectives :
- To demonstrate the reduction in office Blood Pressure following a 8-week regimen of irbesartan / hydrochlorothiazide using irbesartan as a reference.
- To demonstrate the reduction in office Blood Pressure after 4-week regimen of irbesartan / hydrochlorothiazide using irbesartan as a reference.
- To compare the response rate (defined as office Systolic Blood Pressure/Diastolic Blood Pressure reduce more than 10mmHg from Week 0) of patients after 4-week and 8-week regimen of irbesartan / hydrochlorothiazide versus irbesartan.
- To compare the proportion of patients requiring titration after 4-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
- To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus irbesartan when administered once daily
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild to moderate hypertension with office Diastolic Blood Pressure (DBP) 90-109 mmHg and/or Systolic Blood Pressure (SBP) 140-179 mmHg
- •All women of child-bearing potential must have negative urine pregnancy tests within a week prior to initiation of therapy
排除标准
- •females who are pregnant or breast feeding
- •office DBP ≥ 110 mmHg or office SBP ≥ 180 mmHg
- •history of significant cardiovascular diseases which includes:
- •acute myocardial infarction within six months or any ischemic heart disease requiring medication.
- •cerebrovascular disease
- •history of significant renal diseases including:
- •serum creatinine > 3.0 mg/dl.
- •creatinine clearance < 30 ml/min.
- •severe biliary cirrhosis and cholestasis
- •refractory hypokalemia, hypercalcemia
- •history of autoimmune disease, collagen vascular disease, multiple drug allergies, bronchospastic disease or other malignancies requiring current medication
- •hepatic disease as indicated by any of the following:
- •SGOT or SGPT >3 x upper limit of normal.
- •Serum bilirubin > 2 x upper limit of normal.
- •any other condition or therapy that, in the investigator's opinion, or as indicated in the product(s) label may pose a risk to the patient or interfere with the study objectives.
- •any other investigational drug given within 30 days of initiation of therapy, and participation in other clinical studies while enrolled in this protocol.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Compare the reduction in office BP following a 8-week regimen of irbesartan / hydrochlorothiazide versus irbesartan
次要结局
- Compare the reduction in office BP following a 4-week regimen of irbesartan / hydrochlorothiazide versus irbesartan
- Compare the response rate (defined as office SBP/DBP reduce more than 10mmHg from week 0) of patients after 4-week and 8-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
- Compare the proportion of patients requiring titration after 4-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
- Ascertain the safety and tolerability of irbesartan/hydrochlorothiazide versus irbesartan when administered once daily.
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
China Medical University Hospital (CMUH) Triapin ListingHypertensionNCT00841880Sanofi49
已完成
4 期
Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes MellitusHypertensionNCT00927394Novartis1,143
已完成
3 期
Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential HypertensionEssential HypertensionNCT01237223Novartis1,342
已完成
3 期
Efficacy and Safety of Aliskiren 300mg Compared to Irbesartan 300mg and Ramipril 10 mg in the Setting of a Missed Dose for Patients With Essential Hypertension.Essential HypertensionNCT00343551Novartis654
已完成
3 期
Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan or Amlodipine MonotherapyHypertensionNCT01625494Sanofi158