NCT00500604已完成4 期
A Comparative Study of the Efficacy of Irbesartan/Hydrochlorothiazide 300/25 mg Versus Valsartan/Hydrochlorothiazide 160/25 mg Using Home Blood Pressure Monitoring in the Treatment of Mild to Moderate Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,617
- 试验地点
- 1
- 主要终点
- Reduction in mean SBP as measured by HBPM
研究概览
简要总结
The primary objective is to compare the efficacy of irbesartan/hydrochlorothiazide 300/25mg against valsartan/hydrochlorothiazide 160/25mg in reducing mean systolic blood pressure (SBP) as measured by home blood pressure monitoring (HBPM) after 24 weeks compared with baseline.
The secondary objectives are:
- To compare the percentage of patients with normal blood pressure as measured by HBPM and at the doctor's office at weeks 16 and 24
- To compare the differences in mean Diastolic Blood Pressure (DBP), mean morning and evening SBP and DBP evaluated by HBPM at weeks 16 and 24
- To compare the difference in mean SBP evaluated by HBPM at week 16
- To compare the differences in mean SBP and DBP evaluated at the doctor's office at weeks 16 and 24
- To determine the incidence and severity of adverse events
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established essential hypertension, untreated or treated but uncontrolled with treatment:
- •Office SBP ≥ 160 mmHg for untreated patients
- •Office SBP ≥ 140 mmHg for patients already treated with an antihypertensive drug.
- •Previous antihypertensive therapy must have been implemented for a minimum of 4 weeks and must be either monotherapy or one of the following permitted combination drugs:
- •ACE inhibitor / calcium channel blocker
- •Beta blocker / calcium channel blocker
- •Beta blocker / low dose diuretic
- •ACE inhibitor / low dose diuretic
排除标准
- •SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg evaluated at doctor's office at Visit 1
- •Known or suspected causes of secondary hypertension
- •Patient with bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, a renal transplant or only has one functioning kidney
- •Type 1 diabetes mellitus
- •Significant cardiovascular, neurological, endocrine, renal, metabolic, or gastrointestinal disease, a malignancy or any other diseases considered by the Investigator to make participation in the study not in the best interest of the subject
- •Known hypersensitivity to diuretics or sulphonamides or history of angioedema or cough related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used
- •Known contraindications to any of the study drugs
- •Concomitant use of any other antihypertensive treatment
- •Use of any of the investigational products for this study within the 3 months prior to the study
- •Inability to obtain a valid HBPM recording i.e., obesity, arm circumference > 32 cm or arrhythmia
- •Administration of any other investigational drug in the last 30 days before enrolment and during the course of the study
- •Pregnant or breast-feeding women
- •Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
A
Experimental
- period 1: Hydrochlorothiazide 12.5 mg for 3-5 weeks
- period 2: One 150/12.5mg tablet every morning for 8 weeks.
- period 3: One 300/12.5mg tablet every morning for 8 weeks.
- period 4: Two 150/12.5mg tablets every morning for 8 weeks.
干预措施: Irbesartan/hydrochlorothiazide (Drug)
A
Experimental
- period 1: Hydrochlorothiazide 12.5 mg for 3-5 weeks
- period 2: One 150/12.5mg tablet every morning for 8 weeks.
- period 3: One 300/12.5mg tablet every morning for 8 weeks.
- period 4: Two 150/12.5mg tablets every morning for 8 weeks.
干预措施: Hydrochlorothiazide (Drug)
B
Active Comparator
- period 1: Hydrochlorothiazide 12.5 mg for 3-5 weeks
- period 2: One 80/12.5mg tablet every morning for 8 weeks.
- period 3: One 160/12.5mg tablet every morning for 8 weeks.
- period 4: Two 80/12.5mg tablets every morning for 8 weeks.
干预措施: Valsartan/hydrochlorothiazide (Drug)
B
Active Comparator
- period 1: Hydrochlorothiazide 12.5 mg for 3-5 weeks
- period 2: One 80/12.5mg tablet every morning for 8 weeks.
- period 3: One 160/12.5mg tablet every morning for 8 weeks.
- period 4: Two 80/12.5mg tablets every morning for 8 weeks.
干预措施: Hydrochlorothiazide (Drug)
结局指标
主要结局
Reduction in mean SBP as measured by HBPM
时间窗: From week 0 to week 24
次要结局
- Reduction in mean DBP as measured by HBPM(From week 0 to weeks 16 and 24)
- Reduction in mean morning and evening SBP as measured by HBPM(From week 0 to weeks 16 and 24)
- Reduction in mean morning and evening DBP as measured by HBPM(From week 0 to weeks 16 and 24)
- Reduction in mean SBP and mean DBP evaluated at the doctor's office(From week 0 to weeks 16 and 24)
- Number of normalised patients as measured by HBPM(From week 0 to weeks 16 and 24)
- Number of normalised patients evaluated at the doctor's office(From week 0 to weeks 16 and 24)
- Reduction in mean SBP as measured by HBPM(From week 0 to week 16)
- Adverse events, vital signs, laboratory tests(From visit 1 to end of study)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Irbesartan in the Treatment of Hypertensive Patients With Metabolic SyndromeMetabolic SyndromeHypertensionNCT00110422Bristol-Myers Squibb400
已完成
4 期
ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide CombinationHypertensionNCT00708344Sanofi832
已完成
4 期
Effect of the Angiotensin II Receptor Antagonist Irbesartan on Biochemical and Functional Markers of Endothelial Dysfunction in Patients With HypertensionHypertensionNCT00529750Sanofi108
已完成
4 期
Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive PatientsHypertensionNCT00670566Sanofi503
已完成
不适用
Crossover Bioequivalence Study of Irbesartan Hydrochlorothiazide 300/25 mg Tablets Under Fed ConditionsHypertensionNCT01712126Roxane Laboratories40