Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc

ViiV Healthcare18 enrolled

Overview

The objective of this study was to estimate the effects of a single dose of vardenafil on the blood pressure (BP) in subjects receiving maraviroc (MVC) (dosed to steady-state) and to assess the safety and tolerability of MVC in subjects receiving a single dose of vardenafil.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

AIDS

Interventions

MaravirocDRUG

Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Vardenafil 20 mg.

VardenafilDRUG

Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Vardenafil 20 mg.

MaravirocDRUG

Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Placebo.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male subjects. no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram and clinical laboratory tests. * Body mass index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs). Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. * Subjects with a supine systolic BP of greater than 140 mm Hg, or a supine diastolic BP of greater than 90 mm Hg, either at Screening or at the predose measurements.

Locations (1)

Pfizer Investigational Site

Brussels, Belgium

Outcomes

Primary Outcomes

Standing and Supine Systolic and Diastolic Blood Pressure (BP)

Supine BP was taken after subjects rested for 5 minutes supine. Subjects then sat for 2 minutes and stood for 2 minutes then standing BP taken. Duplicate supine and standing BP measurements were taken per the protocol. The average of the duplicate measurements was calculated prior to data analysis.

Time frame: 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose

Secondary Outcomes

Standing and Supine Pulse Rate

Supine pulse rate measurement was taken after subject rested for 5 minutes supine. Subject sat for 2 minutes, then stood for 2 minutes and standing measurement taken. Duplicate supine and standing pulse rate measurements taken per protocol. Average of duplicate measurements calculated prior to data analysis.

Time frame: 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose

Postural Changes in Systolic and Diastolic Blood Pressure

Postural change calculated as position 1 (standing) value minus the position 2 (supine) value. Baseline was the average of 3 predose measurements at each period. Means of replicates were used in calculations.

Time frame: Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg

Postural Changes in Pulse Rate

Postural change calculated as position 1 (standing) value minus position 2 (supine) value. Baseline was the average of the 3 predose measurements at each period. Means of Replicates were used in calculations.

Time frame: Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg

Number of Subjects With Postural Hypotension

Postural (orthostatic) hypotension defined as 1) decrease in standing-supine diastolic blood pressure (BP) greater than or equal to 10 mm Hg; 2) decrease in standing-supine systolic BP greater than or equal to 20 mm Hg; or 3) standing systolic BP less than 90 mm Hg. Assessed at Period 1 and Period 2 BP measurement timepoints post maraviroc dose.

Data from ClinicalTrials.gov

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