NCT00171015已完成3 期
An Open,Multicenter Study to Evaluate the Efficacy and Safety of a 4 Week Therapy With Valsartan/Hydrochlorothiazide 160/25 (Fixed Dose Combination of Valsartan 160 mg Plus HCTZ 25 mg) in Patients Not Adequately Responding to a 4 Week Monotherapy With Olmesartan Medoxomil 40 mg or Combination Therapy With Olmesartan Medoxomil 20 mg Plus HCTZ 12.5 mg
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- Change from baseline in diastolic blood pressure after 4 weeks
研究概览
简要总结
To evaluate the efficacy of valsartan 160 mg/HCTZ 25 mg in patients not adequately responding to monotherapy with olmesartan medoxomil 40 mg or combination therapy with olmesartan medoxomil 20 mg plus HCTZ 12.5 mg by testing the hypothesis that valsartan 160 mg/HCTZ 25 mg significantly reduces the trough mean sitting diastolic blood pressure (MSDBP) after a 4-week treatment in the nonresponder population.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. barrier method with spermicide, intra-uterine device, hormonal contraceptives).
- •Patients with essential hypertension:
- •At Visit 1, untreated patients should have a MSDBP >100 mmHg and < 110 mmHg and treated patients need to have a MSDBP < 110 mmHg. Untreated patients can be included as soon as the safety laboratory parameters are available, but not at the day of Visit
- •This inclusion visit will be recorded as Visit 3 in the CRF.
- •At Visit 2, patients previously treated for hypertension need to have a MSDBP ≥ 100 mmHg and < 110 mmHg for entrance into the first treatment phase. Patients previously treated for hypertension who have a MSDBP < 100 mmHg at Visit 2 will continue the wash-out phase and will be again evaluated with regard to BP criteria at Visit
- •Untreated patients do not perform Visit
- •At Visit 3, which is not performed for patients who entered the first treatment phase already at Visit 2, patients need to have a MSDBP >100 mmHg and < 110 mmHg for entrance into the first treatment phase.
- •At Visit 4, all patients need to have a MSDBP >90 mmHg for entrance into the second treatment phase.
排除标准
- •MSDBP >110 mmHg or MSSBP >180 mmHg
- •Pregnant or nursing women
- •Inability to completely discontinue all antihypertensive medications safely for a period of up to 2 weeks, as required by the protocol
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Change from baseline in diastolic blood pressure after 4 weeks
次要结局
- Diastolic blood pressure less than 90 mmHg or decrease in diastolic blood pressure of 10 mmHg or greater after 4 weeks
- Change from baseline in systolic blood pressure after 4 weeks
- Diastolic blood pressure less than 90 mmHg after 4 weeks
- Change from baseline heart rate after 4 weeks
研究者
研究点 (2)
Loading locations...
相似试验
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
4 期
Efficacy and Safety of Valsartan, Hydrochlorothiazide and Amlodipine Combination Therapy in HypertensionHypertensionNCT00400777Novartis460
已完成
4 期
To Assess the Effects of Valsartan on Albuminuria/Proteinuria in Hypertensive Patients With Type 2 Diabetes MellitusProteinuriaMicroalbuminuriaNCT00550095Novartis509
已完成
3 期
Valsartan/Hydrochlorothiazide Combination in the Treatment of Severe HypertensionHypertensionNCT00273299Novartis607
已完成
4 期
Prevention of CHOP-induced Chronic CardiotoxicityNon-Hodgkin's LymphomaNCT00162955Osaka City University150