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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00853840
First received: February 27, 2009
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
AIDS
 Drug: Maraviroc
Drug: Vardenafil
Drug: Placebo
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Standing and Supine Systolic and Diastolic Blood Pressure (BP) [ Time Frame: 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Standing and Supine Pulse Rate [ Time Frame: 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose ] [ Designated as safety issue: Yes ]
    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.

  • Postural Changes in Systolic and Diastolic Blood Pressure [ Time Frame: Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg ] [ Designated as safety issue: Yes ]
    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.

  • Postural Changes in Pulse Rate [ Time Frame: Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg ] [ Designated as safety issue: Yes ]
    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.

  • Number of Subjects With Postural Hypotension [ Time Frame: Period 1 and Period 2 (up to 8 days) ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 18
Study Start Date: April 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.
Maraviroc + Vardenafil
 Drug: Maraviroc
Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Vardenafil 20 mg.
Other Name: Celsentri, Selzentry
Drug: Vardenafil
Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Vardenafil 20 mg.
Placebo Comparator: 2.
Maraviroc + Placebo
 Drug: Maraviroc
Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Placebo.
Other Name: Selzentry, Celsentri
Drug: Placebo
Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Placebo.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853840

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00853840     History of Changes
Other Study ID Numbers: A4001074
Study First Received: February 27, 2009
Results First Received: May 5, 2009
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ViiV Healthcare:
pharmacodynamics. maraviroc, vardenafil, blood pressure

Additional relevant MeSH terms:
Vardenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013