Phase 4
N=18
Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc
AIDS
Bottom Line
View on ClinicalTrials.gov: NCT00853840 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jun 2009
Primary outcome: Primary: Standing and Supine Systolic and Diastolic Blood Pressure (BP) — 118.36; 119.47; 68.06; 69.99 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Maraviroc (Drug); Vardenafil (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- ViiV Healthcare
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Standing and Supine Systolic and Diastolic Blood Pressure (BP) |
118.36; 119.47; 68.06; 69.99; 113.45; 118.44 | — |
| SECONDARY Standing and Supine Pulse Rate |
67.56; 60.61; 66.20; 60.69; 61.64; 58.00 | — |
| SECONDARY Postural Changes in Systolic and Diastolic Blood Pressure |
3.5; 2.6; 8.9; 7.5; 2.2; 1.5 | — |
| SECONDARY Postural Changes in Pulse Rate |
16.0; 14.3; 22.9; 20.4; 12.0; 12.0 | — |
| SECONDARY Number of Subjects With Postural Hypotension |
0; 0 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00853840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.