NCT00548067已完成3 期
A Multi-center, Multiple Dose, Open-label, Four-cohort, Parallel Study to Assess the Pharmacokinetic Drug Interaction Following Co-administration of Valsartan, Hydrochlorothiazide and Amlodipine in Patients With Hypertension.
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
- Novartis
- 入组人数
- 111
- 试验地点
- 3
- 主要终点
- Potential drug interaction and effect on blood level of drugs when co-administered for 17 days
研究概览
简要总结
The purpose of this study is to determine potential pharmacokinetic drug-drug interaction when three drugs (valsartan, amlodipine, and hydrochlorothiazide) are co-administered.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as hypertensive
- •Untreated confirmed hypertensive patients (consistent SBP >140 mm Hg or DBP >90 mm Hg)
- •Uncontrolled hypertensive patients (Consistent SBP >140 mm Hg or DBP >90 mm Hg) on one drug therapy.
- •Uncontrolled hypertensive patients (Consistent SBP >140 mm Hg or DBP >90 mm Hg) on two drug therapy.
排除标准
- •Inability to switch from all prior antihypertensive medications safely as required by the protocol.
- •Need for drugs other than study drugs at the time of baseline.
- •Patients with SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at screening.
- •Patients on four or more antihypertensive drugs at screening.
- •Pregnant or nursing (lactating) women.
- •Patients with diabetes mellitus
- •Patients with heart diseases and any other disease
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
1
Active Comparator
干预措施: Valsartan/hydrochlorothiazide (HCTZ) (Drug)
2
Active Comparator
干预措施: Valsartan/amlodipine (Drug)
3
Active Comparator
干预措施: Amlodipine/hydrochlorothiazide(HCTZ) (Drug)
4
Experimental
干预措施: Valsartan/amlodipine/hydrochlorothiazide(HCTZ) (Drug)
结局指标
主要结局
Potential drug interaction and effect on blood level of drugs when co-administered for 17 days
次要结局
- Safety and tolerability of co-administered assessed by capturing adverse events and safety laboratory
研究者
研究点 (3)
Loading locations...
相似试验
已完成
1 期
Pharmacokinetics and Drug Interaction Study Between Rosuvastatin and CS-866 in Healthy Male VolunteersHealthyNCT01415466Daewoong Pharmaceutical Co. LTD.36
已完成
1 期
Pharmacokinetics and Drug Interaction Study Between Amlodipine,Olmesartan and Rosuvastatin in Healthy Adult VolunteersHealthyNCT02089399Daewoong Pharmaceutical Co. LTD.32
已完成
2 期
Evaluation of Drug-drug Interaction Between LCZ696 and Sildenafil in Subjects With Mild to Moderate HypertensionMild to Moderate HypertensionNCT01601470Novartis Pharmaceuticals28
已完成
1 期
To Evaluate the Pharmacokinetic Interactions and Safety in Healthy VolunteersHealthyNCT05351840JW Pharmaceutical31
Unknown
1 期
Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With DWC202001 and DWC202002 in Healthy Male AdultsHealthyNCT04343547Daewoong Pharmaceutical Co. LTD.34