An open label, three-period, single sequence study to evaluate the pharmacokinetic drug-drug interaction between LCZ696 and sildenafil in subjects with mild to moderate hypertension

ovartis Pharma Services AG0 个研究点开始时间: 2012年7月11日最近更新: 2013年11月4日

试验速览

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•-Male subjects with mild to moderate hypertension, either treated or not surrently under treatment, between age 18 and 65 years of age, and otherwise in good health as determined by past medical history , physical examination, vital signs, electrocardiogram, and laboratory tests at screening except for hypertension
•- At screening: systolic blood pressure 120-140 mmHg on therapy, or 140-160 mmHg if untreated
•- At screening: diastolic blood pressure, 70-95 mmHg on therapy, or 90-100 mmHg if untreated
•- Baseline:BP >= 140/90
•- Subjects currently on hypertension treatment should be on stable single drug antihypertensive medication during 2 months prior to screening
•For detailed inclusion criteria see the full protocol.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 28
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Use of non-antihypertensive prescription drugs, herbal supplements, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing
•- History of documented symptomatic orthostatic hypotension or syncope
•For detailed exclusion criteria see the full protocol.

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