NCT00171132已完成4 期
A 26-week Double-blind, Randomized, Multicenter Parallel-group Trial to Compare the Effects of Valsartan Versus Atenolol on Exercise Capacity in Hypertensive Overweight Postmenopausal Women With Impaired Exercise Tolerance
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change from baseline in exercise capacity measured by oxygen consumption during exercise testing, after 26 weeks
研究概览
简要总结
The purpose of the study is to show that valsartan compared to atenolol has favorable effects on exercise capacity, quality of life, diastolic function and elevated blood pressure in hypertensive postmenopausal overweight women with impaired exercise tolerance despite normal left ventricular ejection fraction (LVEF).
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) must be ≥ 27 and < 35
- •Symptoms of impaired exercise capacity (e.g. who report shortness of breath on exertion when questioned) reported at Visit 1 or patients who have a history of shortness of breath which improved under diuretic therapy
- •LV ejection fraction must be > 45% measured by echocardiography at Visit
- •Impaired exercise capacity measured by VO2max at Visit 4:
- •VO2max >14 and < 22 ml ⋅kg-1 ⋅min-1
排除标准
- •Mean sitting diastolic blood pressure (MSDBP) ≥ 110 mmHg and/or Mean sitting systolic blood pressure (MSSBP) ≥ 180 mmHg
- •LVEF ≤ 45 %
- •Inability to completely discontinue all previous antihypertensive medications safely for the duration of the study
- •Heavy smokers (>20 cigarettes/day)
结局指标
主要结局
Change from baseline in exercise capacity measured by oxygen consumption during exercise testing, after 26 weeks
次要结局
- Change from baseline in diastolic heart function after 26 weeks, measured by echocardiography
- Change from baseline in heart rate and blood pressure,
- during exercise testing after 26 weeks
- Change from baseline in heart size after 26 weeks, measured by echocardiography
- Change from baseline in quality of life measures after 26 weeks
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKDPediatric Hypertension With or Without CKDNCT01617681Novartis Pharmaceuticals127
已完成
2 期
Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential HypertensionEssential HypertensionNCT00425373Novartis Pharmaceuticals1,474
已完成
3 期
VALID: Study to Compare the Reduction of Predialysis Systolic Blood Pressure With Valsartan Compared to Irbesartan in Patients With Mild to Moderate Hypertension on Long-term HemodialysisHypertensionNCT00171080Novartis86
已完成
3 期
Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood PressureHypertensionNCT00435162Novartis Pharmaceuticals74
已完成
3 期
GISSI-AF - Use of Valsartan an Angiotensin II AT1-Receptor Blocker in the Prevention of Atrial Fibrillation RecurrenceAtrial FibrillationNCT00376272Gruppo di Ricerca GISSI1,442