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

AIDS Clinical Trial

Official title:

A Randomized, Single-Blinded, Placebo-Controlled Two-Way Crossover Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00853840
• Other study ID #: A4001074
• Status: Completed
• Phase: Phase 4
• First received: February 27, 2009
• Last updated: January 16, 2013
• Start date: April 2008
• Est. completion date: May 2008

Study information

• Verified date: January 2013
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS

Intervention

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

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose	Yes
Secondary	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.	1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose	Yes
Secondary	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.	Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg	Yes
Secondary	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.	Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg	Yes
Secondary	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.	Period 1 and Period 2 (up to 8 days)	Yes

External Links

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