Trial Outcomes & Findings for Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc (NCT NCT00853840)
NCT ID: NCT00853840
Last Updated: 2013-01-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
18 participants
Primary outcome timeframe
1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose
Results posted on
2013-01-25
Participant Flow
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).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Period 1
STARTED
|
9
|
9
|
|
Period 1
Maraviroc (Days 1 - 4)
|
9
|
9
|
|
Period 1
Vardenafil or Placebo (Day 4)
|
9
|
9
|
|
Period 1
COMPLETED
|
9
|
9
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
9
|
9
|
|
Period 2
Maraviroc (Days 1 - 3)
|
9
|
9
|
|
Period 2
Vardenafil or Placebo (Day 3)
|
9
|
9
|
|
Period 2
COMPLETED
|
9
|
9
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc
Baseline characteristics by cohort
| Measure |
All Subjects
n=18 Participants
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.
|
|---|---|
|
Age Continuous
|
34.6 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dosePopulation: 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.
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.
Outcome measures
| Measure |
Maraviroc + Vardenafil (Treatment A)
n=18 Participants
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.
|
Maraviroc + Placebo (Treatment B)
n=18 Participants
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.
|
|---|---|---|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Supine Systolic BP: 1.5 hour post Maraviroc dose
|
118.36 mm Hg
Standard Error 1.1523
|
119.47 mm Hg
Standard Error 1.1523
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Supine Diastolic BP: 1.5 hour post Maraviroc dose
|
68.06 mm Hg
Standard Error 0.7184
|
69.99 mm Hg
Standard Error 0.7184
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Supine Systolic BP: 2 hour post Maraviroc dose
|
113.45 mm Hg
Standard Error 1.1523
|
118.44 mm Hg
Standard Error 1.1523
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Supine Diastolic BP: 2 hour post Maraviroc dose
|
66.31 mm Hg
Standard Error 0.7184
|
69.27 mm Hg
Standard Error 0.7184
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Supine Systolic BP: 2.5 hour post Maraviroc dose
|
114.67 mm Hg
Standard Error 1.1523
|
119.55 mm Hg
Standard Error 1.1523
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Supine Diastolic BP: 2.5 hour post Maraviroc dose
|
66.98 mm Hg
Standard Error 0.7184
|
70.80 mm Hg
Standard Error 0.7184
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Supine Systolic BP: 3 hour post Maraviroc dose
|
114.11 mm Hg
Standard Error 1.1523
|
116.16 mm Hg
Standard Error 1.1523
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Supine Diastolic BP: 3 hour post Maraviroc dose
|
67.28 mm Hg
Standard Error 0.7184
|
69.05 mm Hg
Standard Error 0.7184
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Supine Systolic BP: 4 hour post Maraviroc dose
|
115.89 mm Hg
Standard Error 1.1523
|
117.97 mm Hg
Standard Error 1.1523
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Supine Diastolic BP: 4 hour post Maraviroc dose
|
68.37 mm Hg
Standard Error 0.7184
|
69.24 mm Hg
Standard Error 0.7184
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Supine Systolic BP: 6 hour post Maraviroc dose
|
116.45 mm Hg
Standard Error 1.1523
|
118.75 mm Hg
Standard Error 1.1523
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Supine Diastolic BP: 6 hour post Maraviroc dose
|
65.67 mm Hg
Standard Error 0.7184
|
66.52 mm Hg
Standard Error 0.7184
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Supine Systolic BP: 8 hour post Maraviroc dose
|
116.61 mm Hg
Standard Error 1.1523
|
120.83 mm Hg
Standard Error 1.1523
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Supine Diastolic BP: 8 hour post Maraviroc dose
|
66.34 mm Hg
Standard Error 0.7184
|
68.85 mm Hg
Standard Error 0.7184
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Supine Systolic BP: 12 hour post Maraviroc dose
|
122.81 mm Hg
Standard Error 1.1523
|
124.75 mm Hg
Standard Error 1.1523
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Supine Diastolic BP: 12 hour post Maraviroc dose
|
67.95 mm Hg
Standard Error 0.7184
|
70.27 mm Hg
Standard Error 0.7184
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Standing Systolic BP: 1.5 hour post Maraviroc dose
|
120.82 mm Hg
Standard Error 1.6525
|
125.18 mm Hg
Standard Error 1.6525
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Standing Diastolic BP 1.5 hour post Maraviroc dose
|
74.81 mm Hg
Standard Error 1.0102
|
78.74 mm Hg
Standard Error 1.0102
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Standing Systolic BP: 2 hour post Maraviroc dose
|
118.49 mm Hg
Standard Error 1.6525
|
125.40 mm Hg
Standard Error 1.6525
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Standing Diastolic BP: 2 hour post Maraviroc dose
|
74.90 mm Hg
Standard Error 1.0102
|
80.69 mm Hg
Standard Error 1.0102
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Standing Systolic BP: 2.5 hour post Maraviroc dose
|
115.52 mm Hg
Standard Error 1.6525
|
121.32 mm Hg
Standard Error 1.6525
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Standing Diastolic BP 2.5 hour post Maraviroc dose
|
72.29 mm Hg
Standard Error 1.0102
|
78.94 mm Hg
Standard Error 1.0102
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Standing Systolic BP: 3 hour post Maraviroc dose
|
117.10 mm Hg
Standard Error 1.6525
|
121.37 mm Hg
Standard Error 1.6525
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Standing Diastolic BP: 3 hour post Maraviroc dose
|
73.73 mm Hg
Standard Error 1.0102
|
77.38 mm Hg
Standard Error 1.0102
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Standing Systolic BP: 4 hour post Maraviroc dose
|
119.35 mm Hg
Standard Error 1.6525
|
121.40 mm Hg
Standard Error 1.6525
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Standing Diastolic BP: 4 hour post Maraviroc dose
|
77.29 mm Hg
Standard Error 1.0102
|
78.38 mm Hg
Standard Error 1.0102
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Standing Systolic BP: 6 hour post Maraviroc dose
|
118.29 mm Hg
Standard Error 1.6525
|
120.59 mm Hg
Standard Error 1.6525
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Standing Diastolic BP: 6 hour post Maraviroc dose
|
73.34 mm Hg
Standard Error 1.0102
|
76.77 mm Hg
Standard Error 1.0102
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Standing Systolic BP: 8 hour post Maraviroc dose
|
120.43 mm Hg
Standard Error 1.6525
|
123.90 mm Hg
Standard Error 1.6525
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Standing Diastolic BP: 8 hour post Maraviroc dose
|
74.06 mm Hg
Standard Error 1.0102
|
77.32 mm Hg
Standard Error 1.0102
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Standing Systolic BP: 12 hour post Maraviroc dose
|
128.38 mm Hg
Standard Error 1.6525
|
128.65 mm Hg
Standard Error 1.6525
|
|
Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Standing Diastolic BP: 12 hour post Maraviroc dose
|
78.65 mm Hg
Standard Error 1.0102
|
80.91 mm Hg
Standard Error 1.0102
|
SECONDARY outcome
Timeframe: 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dosePopulation: 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.
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.
Outcome measures
| Measure |
Maraviroc + Vardenafil (Treatment A)
n=18 Participants
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.
|
Maraviroc + Placebo (Treatment B)
n=18 Participants
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.
|
|---|---|---|
|
Standing and Supine Pulse Rate
Supine pulse rate: 1.5 hours post Maraviroc dose
|
67.56 beats per minute (bpm)
Standard Error 1.3482
|
60.61 beats per minute (bpm)
Standard Error 1.3482
|
|
Standing and Supine Pulse Rate
Supine pulse rate: 2 hours post Maraviroc dose
|
66.20 beats per minute (bpm)
Standard Error 1.3482
|
60.69 beats per minute (bpm)
Standard Error 1.3482
|
|
Standing and Supine Pulse Rate
Supine pulse rate: 2.5 hours post Maraviroc dose
|
61.64 beats per minute (bpm)
Standard Error 1.3482
|
58.00 beats per minute (bpm)
Standard Error 1.3482
|
|
Standing and Supine Pulse Rate
Supine pulse rate: 3 hours post Maraviroc dose
|
60.42 beats per minute (bpm)
Standard Error 1.3482
|
57.53 beats per minute (bpm)
Standard Error 1.3482
|
|
Standing and Supine Pulse Rate
Supine pulse rate: 4 hours post Maraviroc dose
|
60.22 beats per minute (bpm)
Standard Error 1.3482
|
58.16 beats per minute (bpm)
Standard Error 1.3482
|
|
Standing and Supine Pulse Rate
Supine pulse rate: 6 hours post Maraviroc dose
|
71.39 beats per minute (bpm)
Standard Error 1.3482
|
65.94 beats per minute (bpm)
Standard Error 1.3482
|
|
Standing and Supine Pulse Rate
Supine pulse rate: 8 hours post Maraviroc dose
|
67.67 beats per minute (bpm)
Standard Error 1.3482
|
63.55 beats per minute (bpm)
Standard Error 1.3482
|
|
Standing and Supine Pulse Rate
Supine pulse rate: 12 hours post Maraviroc dose
|
71.25 beats per minute (bpm)
Standard Error 1.3482
|
67.80 beats per minute (bpm)
Standard Error 1.3482
|
|
Standing and Supine Pulse Rate
Standing pulse rate: 1.5 hours post Maraviroc dose
|
85.78 beats per minute (bpm)
Standard Error 1.6885
|
78.45 beats per minute (bpm)
Standard Error 1.6885
|
|
Standing and Supine Pulse Rate
Standing pulse rate: 2 hours post Maraviroc dose
|
85.16 beats per minute (bpm)
Standard Error 1.6885
|
78.34 beats per minute (bpm)
Standard Error 1.6885
|
|
Standing and Supine Pulse Rate
Standing pulse rate: 2.5 hours post Maraviroc dose
|
82.25 beats per minute (bpm)
Standard Error 1.6885
|
77.22 beats per minute (bpm)
Standard Error 1.6885
|
|
Standing and Supine Pulse Rate
Standing pulse rate: 3 hours post Maraviroc dose
|
80.05 beats per minute (bpm)
Standard Error 1.6885
|
75.34 beats per minute (bpm)
Standard Error 1.6885
|
|
Standing and Supine Pulse Rate
Standing pulse rate: 4 hours post Maraviroc dose
|
79.97 beats per minute (bpm)
Standard Error 1.6885
|
75.92 beats per minute (bpm)
Standard Error 1.6885
|
|
Standing and Supine Pulse Rate
Standing pulse rate: 6 hours post Maraviroc dose
|
93.53 beats per minute (bpm)
Standard Error 1.6885
|
87.17 beats per minute (bpm)
Standard Error 1.6885
|
|
Standing and Supine Pulse Rate
Standing pulse rate: 8 hours post Maraviroc dose
|
84.41 beats per minute (bpm)
Standard Error 1.6885
|
79.34 beats per minute (bpm)
Standard Error 1.6885
|
|
Standing and Supine Pulse Rate
Standing pulse rate: 12 hours post Maraviroc dose
|
82.47 beats per minute (bpm)
Standard Error 1.6885
|
80.59 beats per minute (bpm)
Standard Error 1.6885
|
SECONDARY outcome
Timeframe: Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment LegPopulation: 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.
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.
Outcome measures
| Measure |
Maraviroc + Vardenafil (Treatment A)
n=18 Participants
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.
|
Maraviroc + Placebo (Treatment B)
n=18 Participants
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.
|
|---|---|---|
|
Postural Changes in Systolic and Diastolic Blood Pressure
Systolic Blood Pressure: Baseline
|
3.5 mm Hg
Standard Deviation 5.01
|
2.6 mm Hg
Standard Deviation 4.34
|
|
Postural Changes in Systolic and Diastolic Blood Pressure
Diastolic Blood Pressure: Baseline
|
8.9 mm Hg
Standard Deviation 4.69
|
7.5 mm Hg
Standard Deviation 3.41
|
|
Postural Changes in Systolic and Diastolic Blood Pressure
Systolic Blood Pressure: 6 hours
|
2.2 mm Hg
Standard Deviation 5.96
|
1.5 mm Hg
Standard Deviation 5.14
|
|
Postural Changes in Systolic and Diastolic Blood Pressure
Diastolic Blood Pressure: 6 hours
|
8.4 mm Hg
Standard Deviation 4.71
|
9.6 mm Hg
Standard Deviation 4.36
|
|
Postural Changes in Systolic and Diastolic Blood Pressure
Systolic Blood Pressure: 12 hours
|
5.9 mm Hg
Standard Deviation 6.21
|
3.5 mm Hg
Standard Deviation 5.69
|
|
Postural Changes in Systolic and Diastolic Blood Pressure
Diastolic Blood Pressure: 12 hours
|
11.4 mm Hg
Standard Deviation 4.66
|
9.9 mm Hg
Standard Deviation 4.18
|
SECONDARY outcome
Timeframe: Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment LegPopulation: 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.
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.
Outcome measures
| Measure |
Maraviroc + Vardenafil (Treatment A)
n=18 Participants
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.
|
Maraviroc + Placebo (Treatment B)
n=18 Participants
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.
|
|---|---|---|
|
Postural Changes in Pulse Rate
Baseline
|
16.0 beats per minute (bpm)
Standard Deviation 7.32
|
14.3 beats per minute (bpm)
Standard Deviation 8.05
|
|
Postural Changes in Pulse Rate
6 hours
|
22.9 beats per minute (bpm)
Standard Deviation 9.10
|
20.4 beats per minute (bpm)
Standard Deviation 8.25
|
|
Postural Changes in Pulse Rate
12 hours
|
12.0 beats per minute (bpm)
Standard Deviation 6.85
|
12.0 beats per minute (bpm)
Standard Deviation 8.60
|
SECONDARY outcome
Timeframe: Period 1 and Period 2 (up to 8 days)Population: 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.
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.
Outcome measures
| Measure |
Maraviroc + Vardenafil (Treatment A)
n=18 Participants
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.
|
Maraviroc + Placebo (Treatment B)
n=18 Participants
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.
|
|---|---|---|
|
Number of Subjects With Postural Hypotension
|
0 participants
|
0 participants
|
Adverse Events
Maraviroc Run-In
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Maraviroc + Vardenafil (Treatment A)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Maraviroc + Placebo (Treatment B)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Maraviroc Run-In
n=18 participants at risk
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).
|
Maraviroc + Vardenafil (Treatment A)
n=18 participants at risk
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.
|
Maraviroc + Placebo (Treatment B)
n=18 participants at risk
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.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
5.6%
1/18
|
44.4%
8/18
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/18
|
44.4%
8/18
|
0.00%
0/18
|
|
Vascular disorders
Hot flush
|
0.00%
0/18
|
44.4%
8/18
|
0.00%
0/18
|
|
Reproductive system and breast disorders
Erection increased
|
0.00%
0/18
|
16.7%
3/18
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/18
|
11.1%
2/18
|
5.6%
1/18
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18
|
11.1%
2/18
|
11.1%
2/18
|
|
General disorders
Fatigue
|
0.00%
0/18
|
11.1%
2/18
|
0.00%
0/18
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.6%
1/18
|
5.6%
1/18
|
0.00%
0/18
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18
|
5.6%
1/18
|
0.00%
0/18
|
|
Eye disorders
Phosphenes
|
0.00%
0/18
|
5.6%
1/18
|
0.00%
0/18
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18
|
5.6%
1/18
|
0.00%
0/18
|
|
General disorders
Suprapubic pain
|
5.6%
1/18
|
5.6%
1/18
|
0.00%
0/18
|
|
Nervous system disorders
Somnolence
|
0.00%
0/18
|
5.6%
1/18
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/18
|
5.6%
1/18
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/18
|
5.6%
1/18
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
5.6%
1/18
|
5.6%
1/18
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18
|
5.6%
1/18
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/18
|
5.6%
1/18
|
5.6%
1/18
|
|
Eye disorders
Eye pain
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER