Evaluation of Drug-drug Interaction Between LCZ696 and Sildenafil in Subjects With Mild to Moderate Hypertension

Novartis

Status and phase: Completed; Phase 2

Conditions: Mild to Moderate Hypertension

Treatments: Drug: LCZ696; Drug: Sildenafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01601470

CLCZ696B2225

2012-001632-64 (EudraCT Number)

Details and patient eligibility

About

This study was conducted to investigate the potential for a pharmacokinetic drug-drug interaction in support of the co-administration of LCZ696 and sildenafil.

Full description

This study was conducted to investigate the potential for a pharmacokinetic drug-drug interaction in patients with mild-to-moderate hypertension in support of the co-administration of LCZ696 and sildenafil.

Enrollment: 28 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male subjects with mild to moderate hypertension, either treated or not currently on 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.
• 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;

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

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

28 participants in 1 patient group

Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil

Experimental group

Description:

During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696 , co-administered at the same time with a single dose of sildenafil.

Treatment:

Drug: LCZ696

Drug: Sildenafil