NCT00853840

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 2, 2009

Completed
4 months until next milestone

Results Posted

Study results publicly available

June 23, 2009

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

1 month

First QC Date

February 27, 2009

Results QC Date

May 5, 2009

Last Update Submit

January 16, 2013

Conditions

AIDS

Keywords

pharmacodynamics. maraviroc, vardenafil, blood pressure

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Standing and Supine Pulse Rate

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

  • Postural Changes in Systolic and Diastolic Blood Pressure

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

  • Postural Changes in Pulse Rate

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

  • Number of Subjects With Postural Hypotension

    Period 1 and Period 2 (up to 8 days)

Study Arms (2)

1.

EXPERIMENTAL

Maraviroc + Vardenafil

Drug: MaravirocDrug: Vardenafil

2.

PLACEBO COMPARATOR

Maraviroc + Placebo

Drug: MaravirocDrug: Placebo

Interventions

MaravirocDRUG

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

Also known as: Celsentri, Selzentry
1.
VardenafilDRUG

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

1.
PlaceboDRUG

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

2.

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

MaravirocVardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsImidazolesPiperazines

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.govCallCenter@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2009

First Posted

March 2, 2009

Study Start

April 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

January 25, 2013

Results First Posted

June 23, 2009

Record last verified: 2013-01

Locations

BE(1)