Evaluation of drug-drug interaction between LCZ696 and sildenafil in subjects with mild to moderate hypertensio

• Conditions: mild to moderate hypertension; MedDRA version: 14.1Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-001632-64-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-11
• Last Update Posted: 4 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

-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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified