Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc
Sponsor
ViiV Healthcare (Industry)
Overall Status
Completed
CT.gov ID
NCT00853840
Collaborator
Pfizer (Industry)
18
1
2
30
18.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
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
Study Start Date
:
Apr 1, 2008
Actual Primary Completion Date
:
May 1, 2008
Actual Study Completion Date
:
May 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Names:
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 Names:
Drug: Placebo
Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Placebo.
|
Outcome Measures
Primary Outcome Measures
- Standing and Supine Systolic and Diastolic Blood Pressure (BP) [1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose]
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 [1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose]
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 [Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg]
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 [Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg]
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 [Period 1 and Period 2 (up to 8 days)]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Bruxelles | Belgium | 1070 |
Sponsors and Collaborators
- ViiV Healthcare
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00853840
Other Study ID Numbers:
- A4001074
First Posted:
Mar 2, 2009
Last Update Posted:
Jan 25, 2013
Last Verified:
Jan 1, 2013
Keywords provided by ViiV Healthcare
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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). |
| Arm/Group Title | Vardenafil + Maraviroc | Non-matching Placebo + Maraviroc |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Period 1 | ||
| STARTED | 9 | 9 |
| Maraviroc (Days 1 - 4) | 9 | 9 |
| Vardenafil or Placebo (Day 4) | 9 | 9 |
| COMPLETED | 9 | 9 |
| NOT COMPLETED | 0 | 0 |
| Period Title: Period 1 | ||
| STARTED | 9 | 9 |
| Maraviroc (Days 1 - 3) | 9 | 9 |
| Vardenafil or Placebo (Day 3) | 9 | 9 |
| COMPLETED | 9 | 9 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 18 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
34.6
(9.1)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
0
0%
|
| Male |
18
100%
|
Outcome Measures
| Title | Standing and Supine Systolic and Diastolic Blood Pressure (BP) |
|---|---|
| Description | 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. |
| Time Frame | 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Maraviroc + Vardenafil (Treatment A) | Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 18 | 18 |
| Supine Systolic BP: 1.5 hour post Maraviroc dose |
118.36
(1.1523)
|
119.47
(1.1523)
|
| Supine Diastolic BP: 1.5 hour post Maraviroc dose |
68.06
(0.7184)
|
69.99
(0.7184)
|
| Supine Systolic BP: 2 hour post Maraviroc dose |
113.45
(1.1523)
|
118.44
(1.1523)
|
| Supine Diastolic BP: 2 hour post Maraviroc dose |
66.31
(0.7184)
|
69.27
(0.7184)
|
| Supine Systolic BP: 2.5 hour post Maraviroc dose |
114.67
(1.1523)
|
119.55
(1.1523)
|
| Supine Diastolic BP: 2.5 hour post Maraviroc dose |
66.98
(0.7184)
|
70.80
(0.7184)
|
| Supine Systolic BP: 3 hour post Maraviroc dose |
114.11
(1.1523)
|
116.16
(1.1523)
|
| Supine Diastolic BP: 3 hour post Maraviroc dose |
67.28
(0.7184)
|
69.05
(0.7184)
|
| Supine Systolic BP: 4 hour post Maraviroc dose |
115.89
(1.1523)
|
117.97
(1.1523)
|
| Supine Diastolic BP: 4 hour post Maraviroc dose |
68.37
(0.7184)
|
69.24
(0.7184)
|
| Supine Systolic BP: 6 hour post Maraviroc dose |
116.45
(1.1523)
|
118.75
(1.1523)
|
| Supine Diastolic BP: 6 hour post Maraviroc dose |
65.67
(0.7184)
|
66.52
(0.7184)
|
| Supine Systolic BP: 8 hour post Maraviroc dose |
116.61
(1.1523)
|
120.83
(1.1523)
|
| Supine Diastolic BP: 8 hour post Maraviroc dose |
66.34
(0.7184)
|
68.85
(0.7184)
|
| Supine Systolic BP: 12 hour post Maraviroc dose |
122.81
(1.1523)
|
124.75
(1.1523)
|
| Supine Diastolic BP: 12 hour post Maraviroc dose |
67.95
(0.7184)
|
70.27
(0.7184)
|
| Standing Systolic BP: 1.5 hour post Maraviroc dose |
120.82
(1.6525)
|
125.18
(1.6525)
|
| Standing Diastolic BP 1.5 hour post Maraviroc dose |
74.81
(1.0102)
|
78.74
(1.0102)
|
| Standing Systolic BP: 2 hour post Maraviroc dose |
118.49
(1.6525)
|
125.40
(1.6525)
|
| Standing Diastolic BP: 2 hour post Maraviroc dose |
74.90
(1.0102)
|
80.69
(1.0102)
|
| Standing Systolic BP: 2.5 hour post Maraviroc dose |
115.52
(1.6525)
|
121.32
(1.6525)
|
| Standing Diastolic BP 2.5 hour post Maraviroc dose |
72.29
(1.0102)
|
78.94
(1.0102)
|
| Standing Systolic BP: 3 hour post Maraviroc dose |
117.10
(1.6525)
|
121.37
(1.6525)
|
| Standing Diastolic BP: 3 hour post Maraviroc dose |
73.73
(1.0102)
|
77.38
(1.0102)
|
| Standing Systolic BP: 4 hour post Maraviroc dose |
119.35
(1.6525)
|
121.40
(1.6525)
|
| Standing Diastolic BP: 4 hour post Maraviroc dose |
77.29
(1.0102)
|
78.38
(1.0102)
|
| Standing Systolic BP: 6 hour post Maraviroc dose |
118.29
(1.6525)
|
120.59
(1.6525)
|
| Standing Diastolic BP: 6 hour post Maraviroc dose |
73.34
(1.0102)
|
76.77
(1.0102)
|
| Standing Systolic BP: 8 hour post Maraviroc dose |
120.43
(1.6525)
|
123.90
(1.6525)
|
| Standing Diastolic BP: 8 hour post Maraviroc dose |
74.06
(1.0102)
|
77.32
(1.0102)
|
| Standing Systolic BP: 12 hour post Maraviroc dose |
128.38
(1.6525)
|
128.65
(1.6525)
|
| Standing Diastolic BP: 12 hour post Maraviroc dose |
78.65
(1.0102)
|
80.91
(1.0102)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.11 | |
| Confidence Interval |
() 90% -3.80 to 1.59 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.93 | |
| Confidence Interval |
() 90% -3.55 to -0.31 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -4.99 | |
| Confidence Interval |
() 90% -7.69 to -2.30 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.96 | |
| Confidence Interval |
() 90% -4.58 to -1.34 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -4.88 | |
| Confidence Interval |
() 90% -7.58 to -2.19 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -3.82 | |
| Confidence Interval |
() 90% -5.44 to -2.20 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.05 | |
| Confidence Interval |
() 90% -4.74 to 0.64 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.76 | |
| Confidence Interval |
() 90% -3.38 to -0.15 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.08 | |
| Confidence Interval |
() 90% -4.77 to 0.62 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.88 | |
| Confidence Interval |
() 90% -2.49 to 0.74 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.30 | |
| Confidence Interval |
() 90% -4.99 to 0.39 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.85 | |
| Confidence Interval |
() 90% -2.47 to 0.77 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -4.22 | |
| Confidence Interval |
() 90% -6.91 to -1.52 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.51 | |
| Confidence Interval |
() 90% -4.13 to -0.90 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.94 | |
| Confidence Interval |
() 90% -4.63 to 0.76 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.32 | |
| Confidence Interval |
() 90% -3.94 to -0.70 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -4.36 | |
| Confidence Interval |
() 90% -8.22 to -0.50 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -3.93 | |
| Confidence Interval |
() 90% -6.29 to -1.56 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -6.91 | |
| Confidence Interval |
() 90% -10.77 to -3.05 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -5.79 | |
| Confidence Interval |
() 90% -8.15 to -3.42 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -5.80 | |
| Confidence Interval |
() 90% -9.66 to -1.94 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -6.65 | |
| Confidence Interval |
() 90% -9.01 to -4.29 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -4.27 | |
| Confidence Interval |
() 90% -8.13 to -0.41 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -3.65 | |
| Confidence Interval |
() 90% -6.01 to -1.29 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.05 | |
| Confidence Interval |
() 90% -5.91 to 1.81 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.09 | |
| Confidence Interval |
() 90% -3.46 to 1.27 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.30 | |
| Confidence Interval |
() 90% -6.16 to 1.56 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -3.43 | |
| Confidence Interval |
() 90% -5.79 to -1.06 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -3.47 | |
| Confidence Interval |
() 90% -7.33 to 0.39 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -3.26 | |
| Confidence Interval |
() 90% -5.62 to -0.90 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.27 | |
| Confidence Interval |
() 90% -4.13 to 3.59 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.26 | |
| Confidence Interval |
() 90% -4.62 to 0.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Standing and Supine Pulse Rate |
|---|---|
| Description | 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. |
| Time Frame | 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Maraviroc + Vardenafil (Treatment A) | Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 18 | 18 |
| Supine pulse rate: 1.5 hours post Maraviroc dose |
67.56
(1.3482)
|
60.61
(1.3482)
|
| Supine pulse rate: 2 hours post Maraviroc dose |
66.20
(1.3482)
|
60.69
(1.3482)
|
| Supine pulse rate: 2.5 hours post Maraviroc dose |
61.64
(1.3482)
|
58.00
(1.3482)
|
| Supine pulse rate: 3 hours post Maraviroc dose |
60.42
(1.3482)
|
57.53
(1.3482)
|
| Supine pulse rate: 4 hours post Maraviroc dose |
60.22
(1.3482)
|
58.16
(1.3482)
|
| Supine pulse rate: 6 hours post Maraviroc dose |
71.39
(1.3482)
|
65.94
(1.3482)
|
| Supine pulse rate: 8 hours post Maraviroc dose |
67.67
(1.3482)
|
63.55
(1.3482)
|
| Supine pulse rate: 12 hours post Maraviroc dose |
71.25
(1.3482)
|
67.80
(1.3482)
|
| Standing pulse rate: 1.5 hours post Maraviroc dose |
85.78
(1.6885)
|
78.45
(1.6885)
|
| Standing pulse rate: 2 hours post Maraviroc dose |
85.16
(1.6885)
|
78.34
(1.6885)
|
| Standing pulse rate: 2.5 hours post Maraviroc dose |
82.25
(1.6885)
|
77.22
(1.6885)
|
| Standing pulse rate: 3 hours post Maraviroc dose |
80.05
(1.6885)
|
75.34
(1.6885)
|
| Standing pulse rate: 4 hours post Maraviroc dose |
79.97
(1.6885)
|
75.92
(1.6885)
|
| Standing pulse rate: 6 hours post Maraviroc dose |
93.53
(1.6885)
|
87.17
(1.6885)
|
| Standing pulse rate: 8 hours post Maraviroc dose |
84.41
(1.6885)
|
79.34
(1.6885)
|
| Standing pulse rate: 12 hours post Maraviroc dose |
82.47
(1.6885)
|
80.59
(1.6885)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 1.5 hour post-dose for supine pulse rate Vardenafil minus Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 6.95 | |
| Confidence Interval |
() 90% 4.18 to 9.72 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 2 hour post-dose for supine pulse rate Vardenafil minus Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.51 | |
| Confidence Interval |
() 90% 2.73 to 8.28 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 2.5 hour post-dose for supine pulse rate Vardenafil minus Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.64 | |
| Confidence Interval |
() 90% 0.87 to 6.42 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 3 hour post-dose for supine pulse rate Vardenafil minus Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.89 | |
| Confidence Interval |
() 90% 0.12 to 5.67 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 4 hour post-dose for supine pulse rate Vardenafil minus Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.06 | |
| Confidence Interval |
() 90% -0.71 to 4.83 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 6 hour post-dose for supine pulse rate Vardenafil minus Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.45 | |
| Confidence Interval |
() 90% 2.68 to 8.22 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 8 hour post-dose for supine pulse rate Vardenafil minus Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.12 | |
| Confidence Interval |
() 90% 1.34 to 6.89 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 12 hour post-dose for supine pulse rate Vardenafil minus Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.45 | |
| Confidence Interval |
() 90% 0.68 to 6.22 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 1.5 hour post-dose for standing pulse rate Vardenafil minus Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 7.33 | |
| Confidence Interval |
() 90% 3.70 to 10.95 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 2 hour post-dose for standing pulse rate Vardenafil minus Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 6.83 | |
| Confidence Interval |
() 90% 3.20 to 10.45 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 2.5 hour post-dose for standing pulse rate Vardenafil minus Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.02 | |
| Confidence Interval |
() 90% 1.40 to 8.65 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 3 hour post-dose for standing pulse rate Vardenafil minus Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.72 | |
| Confidence Interval |
() 90% 1.09 to 8.34 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 4 hour post-dose for standing pulse rate Vardenafil minus Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.05 | |
| Confidence Interval |
() 90% 0.43 to 7.67 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 6 hour post-dose for standing pulse rate Vardenafil minus Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 6.36 | |
| Confidence Interval |
() 90% 2.73 to 9.98 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 8 hour post-dose for standing pulse rate Vardenafil minus Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.08 | |
| Confidence Interval |
() 90% 1.45 to 8.70 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Comments | 12 hour post-dose for standing pulse rate Vardenafil minus Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.88 | |
| Confidence Interval |
() 90% -1.74 to 5.51 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Postural Changes in Systolic and Diastolic Blood Pressure |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Maraviroc + Vardenafil (Treatment A) | Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 18 | 18 |
| Systolic Blood Pressure: Baseline |
3.5
(5.01)
|
2.6
(4.34)
|
| Diastolic Blood Pressure: Baseline |
8.9
(4.69)
|
7.5
(3.41)
|
| Systolic Blood Pressure: 6 hours |
2.2
(5.96)
|
1.5
(5.14)
|
| Diastolic Blood Pressure: 6 hours |
8.4
(4.71)
|
9.6
(4.36)
|
| Systolic Blood Pressure: 12 hours |
5.9
(6.21)
|
3.5
(5.69)
|
| Diastolic Blood Pressure: 12 hours |
11.4
(4.66)
|
9.9
(4.18)
|
| Title | Postural Changes in Pulse Rate |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Maraviroc + Vardenafil (Treatment A) | Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 18 | 18 |
| Baseline |
16.0
(7.32)
|
14.3
(8.05)
|
| 6 hours |
22.9
(9.10)
|
20.4
(8.25)
|
| 12 hours |
12.0
(6.85)
|
12.0
(8.60)
|
| Title | Number of Subjects With Postural Hypotension |
|---|---|
| Description | 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. |
| Time Frame | Period 1 and Period 2 (up to 8 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Maraviroc + Vardenafil (Treatment A) | Maraviroc + Placebo (Treatment B) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 18 | 18 |
| Number [participants] |
0
0%
|
0
NaN
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Maraviroc Run-In | Maraviroc + Vardenafil (Treatment A) | Maraviroc + Placebo (Treatment B) | |||
| Arm/Group Description | 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). | On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was to be 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. | 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 non-matching placebo tablet was administered orally 1 hour post maraviroc dosing. | |||
All Cause Mortality |
||||||
| Maraviroc Run-In | Maraviroc + Vardenafil (Treatment A) | Maraviroc + Placebo (Treatment B) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Maraviroc Run-In | Maraviroc + Vardenafil (Treatment A) | Maraviroc + Placebo (Treatment B) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Maraviroc Run-In | Maraviroc + Vardenafil (Treatment A) | Maraviroc + Placebo (Treatment B) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/ (NaN) | 16/ (NaN) | 5/ (NaN) | |||
| Eye disorders | ||||||
| Phosphenes | 0/18 (0%) | 1/18 (5.6%) | 0/18 (0%) | |||
| Eye pain | 0/18 (0%) | 0/18 (0%) | 1/18 (5.6%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal discomfort | 1/18 (5.6%) | 1/18 (5.6%) | 0/18 (0%) | |||
| Diarrhoea | 0/18 (0%) | 1/18 (5.6%) | 0/18 (0%) | |||
| Nausea | 0/18 (0%) | 1/18 (5.6%) | 0/18 (0%) | |||
| Dyspepsia | 0/18 (0%) | 0/18 (0%) | 1/18 (5.6%) | |||
| General disorders | ||||||
| Fatigue | 0/18 (0%) | 2/18 (11.1%) | 0/18 (0%) | |||
| Suprapubic pain | 1/18 (5.6%) | 1/18 (5.6%) | 0/18 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Tooth fracture | 1/18 (5.6%) | 1/18 (5.6%) | 1/18 (5.6%) | |||
| Investigations | ||||||
| Hepatic enzyme increased | 0/18 (0%) | 0/18 (0%) | 1/18 (5.6%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Sensation of heaviness | 0/18 (0%) | 2/18 (11.1%) | 1/18 (5.6%) | |||
| Back pain | 1/18 (5.6%) | 1/18 (5.6%) | 1/18 (5.6%) | |||
| Arthralgia | 0/18 (0%) | 1/18 (5.6%) | 1/18 (5.6%) | |||
| Myalgia | 0/18 (0%) | 0/18 (0%) | 1/18 (5.6%) | |||
| Nervous system disorders | ||||||
| Headache | 1/18 (5.6%) | 8/18 (44.4%) | 1/18 (5.6%) | |||
| Dizziness | 0/18 (0%) | 2/18 (11.1%) | 2/18 (11.1%) | |||
| Somnolence | 0/18 (0%) | 1/18 (5.6%) | 0/18 (0%) | |||
| Dizziness postural | 0/18 (0%) | 0/18 (0%) | 1/18 (5.6%) | |||
| Reproductive system and breast disorders | ||||||
| Erection increased | 0/18 (0%) | 3/18 (16.7%) | 0/18 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Nasal congestion | 0/18 (0%) | 8/18 (44.4%) | 0/18 (0%) | |||
| Nasal dryness | 0/18 (0%) | 1/18 (5.6%) | 0/18 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Rash | 0/18 (0%) | 1/18 (5.6%) | 0/18 (0%) | |||
| Vascular disorders | ||||||
| Hot flush | 0/18 (0%) | 8/18 (44.4%) | 0/18 (0%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.govCallCenter@pfizer.com |
Responsible Party:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00853840
Other Study ID Numbers:
- A4001074
First Posted:
Mar 2, 2009
Last Update Posted:
Jan 25, 2013
Last Verified:
Jan 1, 2013