Trial Outcomes & Findings for Research Evaluating an Investigational Medication for Erectile Dysfunction - General ED (NCT NCT00790751)
NCT ID: NCT00790751
Last Updated: 2012-07-11
Results Overview
Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 "Did your erection last long enough for you to have successful intercourse?"
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
646 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2012-07-11
Participant Flow
Subject recruitment occurred at US investigative sites between November 2008 and April 2009.
Subjects meeting the initial eligibility criteria completed a 4-week non-treatment run-in period during which information on each attempt at intercourse was recorded. At the end of the run-in, subjects meeting the randomization criteria were eligible for assignment to one of the treatment groups.
Participant milestones
| Measure |
Placebo
placebo 30 minutes orally prior to initiation of sexual activity
|
Avanafil 50 mg
avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
|
Avanafil 100 mg
avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
|
Avanafil 200 mg
avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
162
|
161
|
161
|
162
|
|
Overall Study
COMPLETED
|
137
|
131
|
141
|
141
|
|
Overall Study
NOT COMPLETED
|
25
|
30
|
20
|
21
|
Reasons for withdrawal
| Measure |
Placebo
placebo 30 minutes orally prior to initiation of sexual activity
|
Avanafil 50 mg
avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
|
Avanafil 100 mg
avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
|
Avanafil 200 mg
avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
|
|---|---|---|---|---|
|
Overall Study
Protocol non-compliance
|
16
|
16
|
10
|
11
|
|
Overall Study
Lost to Follow-up
|
4
|
9
|
4
|
5
|
|
Overall Study
Adverse Event
|
5
|
3
|
5
|
4
|
|
Overall Study
Requirement for restricted medication
|
0
|
2
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Research Evaluating an Investigational Medication for Erectile Dysfunction - General ED
Baseline characteristics by cohort
| Measure |
Placebo
n=162 Participants
placebo 30 minutes orally prior to initiation of sexual activity
|
Avanafil 50 mg
n=161 Participants
avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
|
Avanafil 100 mg
n=161 Participants
avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
|
Avanafil 200 mg
n=162 Participants
avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
|
Total
n=646 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
55.4 years
STANDARD_DEVIATION 11.13 • n=93 Participants
|
55.4 years
STANDARD_DEVIATION 10.81 • n=4 Participants
|
56.5 years
STANDARD_DEVIATION 10.32 • n=27 Participants
|
55.7 years
STANDARD_DEVIATION 11.33 • n=483 Participants
|
55.7 years
STANDARD_DEVIATION 10.89 • n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
162 Participants
n=93 Participants
|
161 Participants
n=4 Participants
|
161 Participants
n=27 Participants
|
162 Participants
n=483 Participants
|
646 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
162 participants
n=93 Participants
|
161 participants
n=4 Participants
|
161 participants
n=27 Participants
|
162 participants
n=483 Participants
|
646 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Number of participants analyzed represents the Intent-to-Treat population.
Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 "Did your erection last long enough for you to have successful intercourse?"
Outcome measures
| Measure |
Placebo
n=155 Participants
placebo 30 minutes orally prior to initiation of sexual activity
|
Avanafil 50 mg
n=154 Participants
avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
|
Avanafil 100 mg
n=157 Participants
avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
|
Avanafil 200 mg
n=156 Participants
avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
|
|---|---|---|---|---|
|
Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse
|
14.1 percentage of sexual attempts
Standard Error 2.57
|
27.8 percentage of sexual attempts
Standard Error 2.58
|
43.4 percentage of sexual attempts
Standard Error 2.56
|
44.2 percentage of sexual attempts
Standard Error 2.57
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Number of participants analyzed represents the Intent-to-Treat population.
Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 "Were you able to insert your penis into your partner's vagina?"
Outcome measures
| Measure |
Placebo
n=155 Participants
placebo 30 minutes orally prior to initiation of sexual activity
|
Avanafil 50 mg
n=154 Participants
avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
|
Avanafil 100 mg
n=157 Participants
avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
|
Avanafil 200 mg
n=156 Participants
avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
|
|---|---|---|---|---|
|
Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina
|
7.1 percentage of sexual attempts
Standard Error 2.33
|
18.2 percentage of sexual attempts
Standard Error 2.34
|
27.2 percentage of sexual attempts
Standard Error 2.32
|
29.8 percentage of sexual attempts
Standard Error 2.33
|
PRIMARY outcome
Timeframe: Baseline, End of Treatment (up to 12 weeks)Population: Number of participants analyzed represents the Intent-to-Treat population. For dropouts or missing data, the last observation carried forward convention was used.
Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 \& 15 ranges from 1 to 30. A higher score indicates better erectile function.
Outcome measures
| Measure |
Placebo
n=152 Participants
placebo 30 minutes orally prior to initiation of sexual activity
|
Avanafil 50 mg
n=152 Participants
avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
|
Avanafil 100 mg
n=156 Participants
avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
|
Avanafil 200 mg
n=155 Participants
avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
|
|---|---|---|---|---|
|
Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score
|
2.9 scores on a scale
Standard Error 0.57
|
5.4 scores on a scale
Standard Error 0.57
|
8.3 scores on a scale
Standard Error 0.56
|
9.5 scores on a scale
Standard Error 0.56
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Avanafil 50 mg
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Avanafil 100 mg
Serious events: 3 serious events
Other events: 28 other events
Deaths: 0 deaths
Avanafil 200 mg
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=161 participants at risk
placebo 30 minutes orally prior to initiation of sexual activity
|
Avanafil 50 mg
n=160 participants at risk
avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
|
Avanafil 100 mg
n=161 participants at risk
avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
|
Avanafil 200 mg
n=162 participants at risk
avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.62%
1/160 • Number of events 1 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.00%
0/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.00%
0/162 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.00%
0/160 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.00%
0/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.62%
1/162 • Number of events 1 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.00%
0/160 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.62%
1/161 • Number of events 1 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.00%
0/162 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage I
|
0.00%
0/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.00%
0/160 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.62%
1/161 • Number of events 1 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.00%
0/162 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
|
Infections and infestations
Infected bites
|
0.00%
0/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.00%
0/160 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.00%
0/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.62%
1/162 • Number of events 1 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.00%
0/160 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.62%
1/161 • Number of events 1 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.00%
0/162 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.00%
0/160 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.00%
0/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.62%
1/162 • Number of events 1 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
|
General disorders
Non-cardiac chest pain
|
0.62%
1/161 • Number of events 1 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.00%
0/160 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.00%
0/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.00%
0/162 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
|
Psychiatric disorders
Depression suicidal
|
0.62%
1/161 • Number of events 1 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.00%
0/160 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.00%
0/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.00%
0/162 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
Other adverse events
| Measure |
Placebo
n=161 participants at risk
placebo 30 minutes orally prior to initiation of sexual activity
|
Avanafil 50 mg
n=160 participants at risk
avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
|
Avanafil 100 mg
n=161 participants at risk
avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
|
Avanafil 200 mg
n=162 participants at risk
avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
1.2%
2/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.62%
1/160 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
1.2%
2/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
3.7%
6/162 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
|
Infections and infestations
Bronchitis
|
0.62%
1/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
1.9%
3/160 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.62%
1/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
2.5%
4/162 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
|
Nervous system disorders
Headache
|
1.2%
2/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
4.4%
7/160 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
7.5%
12/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
9.3%
15/162 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
|
Vascular disorders
Flushing
|
0.00%
0/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
3.8%
6/160 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
6.2%
10/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
3.7%
6/162 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.2%
2/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
0.62%
1/160 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
4.3%
7/161 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
1.9%
3/162 • AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
|
Additional Information
Wesley W Day PhD
Vivus, Inc
Phone: 650-934-5200
Results disclosure agreements
- Principal investigator is a sponsor employee After Sponsor's written notification that publication of results is no longer planned or 12 months after termination of the study at all sites, Institution \& PI may publish, upon written approval from Sponsor, results of the Study. Sponsor will be given the opportunity to review any proposed publication at least 60 days prior to submission for publication or disclosure. Upon Sponsor's written request, Institution and PI shall not publish or disclose information related to the Study.
- Publication restrictions are in place
Restriction type: OTHER