Study To Investigate The Hemodynamic Effects Of Single Do... | NCT00853840

Name	Class
Pfizer	INDUSTRY

Study To Investigate The Hemodynamic Effects Of Single Do... | NCT00853840 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
1.	Experimental	Maraviroc + Vardenafil	Drug: Maraviroc Drug: Vardenafil
2.	Placebo Comparator	Maraviroc + Placebo	Drug: Maraviroc Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Maraviroc	Drug	Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Vardenafil 20 mg.	1.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Brussels		1070	Belgium

Label	URL
To obtain contact information for a study center near you, click here.	View source

Arm/Group Information

ID	Title	Description
FG000	Vardenafil + Maraviroc	On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
FG001	Non-matching Placebo + Maraviroc	On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.

Periods

Title

Milestones

Reasons Not Completed

Period 1

Type	Comment	Milestone Data
STARTED		FG0009 subjects FG0019 subjects
Maraviroc (Days 1 - 4)		FG0009 subjects FG0019 subjects
Vardenafil or Placebo (Day 4)		FG0009 subjectsAdministered 1 hour post Maraviroc dosing FG0019 subjectsAdministered 1 hour post Maraviroc dosing
COMPLETED		FG0009 subjects FG0019 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects

Period 2

Type	Comment	Milestone Data
STARTED		FG0009 subjects FG0019 subjects
Maraviroc (Days 1 - 3)		FG0009 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	All Subjects	In this 2-way crossover study, in Period 1, all 18 subjects were randomized to receive a single dose of either vardenafil 20 mg (Treatment A) or placebo (Treatment B), subsequent to treatment with 3 to 4 days of maraviroc 300 mg BID. All subjects were then crossed over to receive the second treatment in Period 2.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.

Posted

Least Squares Mean

Standard Error

mm Hg

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

ID	Title	Description
OG000	Maraviroc + Vardenafil (Treatment A)	On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Maraviroc Run-In	All subjects received 3 to 4 days of maraviroc 300 mg twice daily (BID) before receiving single oral doses of either vardenafil 20 mg (Treatment A) or placebo (Treatment B).

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Headache	Nervous system disorders	MedDRA (v10.1)	Systematic Assessment

More Info Module

Certain Agreements

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

Condition Browse Module

ID	Term
D000163	Acquired Immunodeficiency Syndrome

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Intervention Browse Module

ID	Term
D000077592	Maraviroc
D000069058	Vardenafil Dihydrochloride

ID	Term
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic

Title

Denominators

Categories

Supine Systolic BP: 1.5 hour post Maraviroc dose

Title	Measurements
	OG000118.36± 1.1523 OG001119.47± 1.1523

Supine Diastolic BP: 1.5 hour post Maraviroc dose

Title	Measurements
	OG00068.06± 0.7184 OG00169.99± 0.7184

Supine Systolic BP: 2 hour post Maraviroc dose

Title	Measurements
	OG000113.45± 1.1523 OG001118.44± 1.1523

Supine Diastolic BP: 2 hour post Maraviroc dose

Title	Measurements
	OG00066.31± 0.7184 OG00169.27± 0.7184

Supine Systolic BP: 2.5 hour post Maraviroc dose

Title	Measurements
	OG000114.67± 1.1523 OG001119.55± 1.1523

Supine Diastolic BP: 2.5 hour post Maraviroc dose

Title	Measurements
	OG00066.98± 0.7184 OG00170.80± 0.7184

Supine Systolic BP: 3 hour post Maraviroc dose

Title	Measurements
	OG000114.11± 1.1523 OG001116.16± 1.1523

Supine Diastolic BP: 3 hour post Maraviroc dose

Title	Measurements
	OG00067.28± 0.7184 OG00169.05± 0.7184

Supine Systolic BP: 4 hour post Maraviroc dose

Title	Measurements
	OG000115.89± 1.1523 OG001117.97± 1.1523

Supine Diastolic BP: 4 hour post Maraviroc dose

Title	Measurements
	OG00068.37± 0.7184 OG00169.24± 0.7184

Supine Systolic BP: 6 hour post Maraviroc dose

Title	Measurements
	OG000116.45± 1.1523 OG001118.75± 1.1523

Supine Diastolic BP: 6 hour post Maraviroc dose

Title	Measurements
	OG00065.67± 0.7184 OG00166.52± 0.7184

Supine Systolic BP: 8 hour post Maraviroc dose

Title	Measurements
	OG000116.61± 1.1523 OG001120.83± 1.1523

Supine Diastolic BP: 8 hour post Maraviroc dose

Title	Measurements
	OG00066.34± 0.7184 OG00168.85± 0.7184

Supine Systolic BP: 12 hour post Maraviroc dose

Title	Measurements
	OG000122.81± 1.1523 OG001124.75± 1.1523

Supine Diastolic BP: 12 hour post Maraviroc dose

Title	Measurements
	OG00067.95± 0.7184 OG00170.27± 0.7184

Standing Systolic BP: 1.5 hour post Maraviroc dose

Title	Measurements
	OG000120.82± 1.6525 OG001125.18± 1.6525

Standing Diastolic BP 1.5 hour post Maraviroc dose

Title	Measurements
	OG00074.81± 1.0102 OG00178.74± 1.0102

Standing Systolic BP: 2 hour post Maraviroc dose

Title	Measurements
	OG000118.49± 1.6525 OG001125.40± 1.6525

Standing Diastolic BP: 2 hour post Maraviroc dose

Title	Measurements
	OG00074.90± 1.0102 OG00180.69± 1.0102

Standing Systolic BP: 2.5 hour post Maraviroc dose

Title	Measurements
	OG000115.52± 1.6525 OG001121.32± 1.6525

Standing Diastolic BP 2.5 hour post Maraviroc dose

Title	Measurements
	OG00072.29± 1.0102 OG00178.94± 1.0102

Standing Systolic BP: 3 hour post Maraviroc dose

Title	Measurements
	OG000117.10± 1.6525 OG001121.37± 1.6525

Standing Diastolic BP: 3 hour post Maraviroc dose

Title	Measurements
	OG00073.73± 1.0102 OG00177.38± 1.0102

Standing Systolic BP: 4 hour post Maraviroc dose

Title	Measurements
	OG000119.35± 1.6525 OG001121.40± 1.6525

Standing Diastolic BP: 4 hour post Maraviroc dose

Title	Measurements
	OG00077.29± 1.0102 OG00178.38± 1.0102

Standing Systolic BP: 6 hour post Maraviroc dose

Title	Measurements
	OG000118.29± 1.6525 OG001120.59± 1.6525

Standing Diastolic BP: 6 hour post Maraviroc dose

Title	Measurements
	OG00073.34± 1.0102 OG00176.77± 1.0102

Standing Systolic BP: 8 hour post Maraviroc dose

Title	Measurements
	OG000120.43± 1.6525 OG001123.90± 1.6525

Standing Diastolic BP: 8 hour post Maraviroc dose

Title	Measurements
	OG00074.06± 1.0102 OG00177.32± 1.0102

Standing Systolic BP: 12 hour post Maraviroc dose

Title	Measurements
	OG000128.38± 1.6525 OG001128.65± 1.6525

Standing Diastolic BP: 12 hour post Maraviroc dose

Title	Measurements
	OG00078.65± 1.0102 OG00180.91± 1.0102

Group IDs	Group Description	Statistical Method	Statistical Comment	Parameter Type	Parameter Value	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	1.5 hour post-dose for supine systolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-1.11	90	-3.80	1.59	No	Superiority or Other
OG000 OG001	1.5 hour post-dose for supine diastolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-1.93	90	-3.55	-0.31	No	Superiority or Other
OG000 OG001	2 hour post-dose for supine systolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-4.99	90	-7.69	-2.30	No	Superiority or Other
OG000 OG001	2 hour post-dose for supine diastolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-2.96	90	-4.58	-1.34	No	Superiority or Other
OG000 OG001	2.5 hour post-dose for supine systolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-4.88	90	-7.58	-2.19	No	Superiority or Other
OG000 OG001	2.5 hour post-dose for supine diastolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-3.82	90	-5.44	-2.20	No	Superiority or Other
OG000 OG001	3 hour post-dose for supine systolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-2.05	90	-4.74	0.64	No	Superiority or Other
OG000 OG001	3 hour post-dose for supine diastolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-1.76	90	-3.38	-0.15	No	Superiority or Other
OG000 OG001	4 hour post-dose for supine systolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-2.08	90	-4.77	0.62	No	Superiority or Other
OG000 OG001	4 hour post-dose for supine diastolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-0.88	90	-2.49	0.74	No	Superiority or Other
OG000 OG001	6 hour post-dose for supine systolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-2.30	90	-4.99	0.39	No	Superiority or Other
OG000 OG001	6 hour post-dose for supine diastolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-0.85	90	-2.47	0.77	No	Superiority or Other
OG000 OG001	8 hour post-dose for supine systolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-4.22	90	-6.91	-1.52	No	Superiority or Other
OG000 OG001	8 hour post-dose for supine diastolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-2.51	90	-4.13	-0.90	No	Superiority or Other
OG000 OG001	12 hour post-dose for supine systolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-1.94	90	-4.63	0.76	No	Superiority or Other
OG000 OG001	12 hour post-dose for supine diastolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-2.32	90	-3.94	-0.70	No	Superiority or Other
OG000 OG001	1.5 hour post-dose for standing systolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-4.36	90	-8.22	-0.50	No	Superiority or Other
OG000 OG001	1.5 hour post-dose for standing diastolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-3.93	90	-6.29	-1.56	No	Superiority or Other
OG000 OG001	2 hour post-dose for standing systolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-6.91	90	-10.77	-3.05	No	Superiority or Other
OG000 OG001	2 hour post-dose for standing diastolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-5.79	90	-8.15	-3.42	No	Superiority or Other
OG000 OG001	2.5 hour post-dose for standing systolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-5.80	90	-9.66	-1.94	No	Superiority or Other
OG000 OG001	2.5 hour post-dose for standing diastolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-6.65	90	-9.01	-4.29	No	Superiority or Other
OG000 OG001	3 hour post-dose for standing systolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-4.27	90	-8.13	-0.41	No	Superiority or Other
OG000 OG001	3 hour post-dose for standing diastolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-3.65	90	-6.01	-1.29	No	Superiority or Other
OG000 OG001	4 hour post-dose for standing systolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-2.05	90	-5.91	1.81	No	Superiority or Other
OG000 OG001	4 hour post-dose for standing diastolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-1.09	90	-3.46	1.27	No	Superiority or Other
OG000 OG001	6 hour post-dose for standing systolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-2.30	90	-6.16	1.56	No	Superiority or Other
OG000 OG001	6 hour post-dose for standing diastolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-3.43	90	-5.79	-1.06	No	Superiority or Other
OG000 OG001	8 hour post-dose for standing systolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-3.47	90	-7.33	0.39	No	Superiority or Other
OG000 OG001	8 hour post-dose for standing diastolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-3.26	90	-5.62	-0.90	No	Superiority or Other
OG000 OG001	12 hour post-dose for standing systolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-0.27	90	-4.13	3.59	No	Superiority or Other
OG000 OG001	12 hour post-dose for standing diastolic BP Vardenafil minus Placebo A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.	Mean Difference (Final Values)	-2.26	90	-4.62	0.10	No	Superiority or Other

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.

The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.

Posted

Least Squares Mean

Standard Error

beats per minute (bpm)

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

ID	Title	Description
OG000	Maraviroc + Vardenafil (Treatment A)	On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
OG001	Maraviroc + Placebo (Treatment B)	On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.

Units	Counts
Participants	OG00018 OG00118

Title

Denominators

Categories

Supine pulse rate: 1.5 hours post Maraviroc dose

Title	Measurements
	OG00067.56± 1.3482 OG00160.61± 1.3482

Supine pulse rate: 2 hours post Maraviroc dose

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	1.5 hour post-dose for supine pulse rate Vardenafil minus Placebo	Mixed Models Analysis	Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.			Mean Difference (Final Values)	6.95				90	4.18	9.72				No	Superiority or Other

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.

The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.

Posted

Mean

Standard Deviation

mm Hg

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

ID	Title	Description
OG000	Maraviroc + Vardenafil (Treatment A)	On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
OG001	Maraviroc + Placebo (Treatment B)	On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.

Units	Counts
Participants	OG00018 OG00118

Title

Denominators

Categories

Systolic Blood Pressure: Baseline

Title	Measurements
	OG0003.5± 5.01 OG0012.6± 4.34

Diastolic Blood Pressure: Baseline

Title	Measurements
	OG000

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.

The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.

Posted

Mean

Standard Deviation

beats per minute (bpm)

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

ID	Title	Description
OG000	Maraviroc + Vardenafil (Treatment A)	On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
OG001	Maraviroc + Placebo (Treatment B)	On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.

Units	Counts
Participants	OG00018 OG00118

Title

Denominators

Categories

Baseline

Title	Measurements
	OG00016.0± 7.32 OG00114.3± 8.05

6 hours

Title	Measurements
	OG000

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.

The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.

Posted

Number

participants

Period 1 and Period 2 (up to 8 days)

ID	Title	Description
OG000	Maraviroc + Vardenafil (Treatment A)	On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
OG001	Maraviroc + Placebo (Treatment B)	On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.

Units	Counts
Participants	OG00018 OG00118

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010