Trial Outcomes & Findings for The Study of AZD8529 for Smoking Cessation in Female Smokers (NCT NCT02401022)
NCT ID: NCT02401022
Last Updated: 2017-11-29
Results Overview
The number of subjects in each treatment group who are smoking abstinence during the last 4 weeks of the treatment phase (weeks 10 through 13)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
214 participants
Primary outcome timeframe
Weeks 10 - 13
Results posted on
2017-11-29
Participant Flow
Participant milestones
| Measure |
AZD8529 Low Dose
Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks
|
AZD8529 High Dose
Participants received AZD8529 40 mg capsule orally once daily for 13 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
110
|
|
Overall Study
COMPLETED
|
89
|
90
|
|
Overall Study
NOT COMPLETED
|
15
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Study of AZD8529 for Smoking Cessation in Female Smokers
Baseline characteristics by cohort
| Measure |
AZD8529 Low Dose
n=104 Participants
Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks
|
AZD8529 High Dose
n=110 Participants
Participants received AZD8529 40 mg capsule orally once daily for 13 weeks
|
Total
n=214 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.3 years
STANDARD_DEVIATION 9.34 • n=5 Participants
|
47.3 years
STANDARD_DEVIATION 9.63 • n=7 Participants
|
47.8 years
STANDARD_DEVIATION 9.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
91 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 10 - 13Population: Subjects who received at least one dose of AZD8529 were included in this population.
The number of subjects in each treatment group who are smoking abstinence during the last 4 weeks of the treatment phase (weeks 10 through 13)
Outcome measures
| Measure |
AZD8529 Low Dose
n=104 Participants
Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks
|
AZD8529 High Dose
n=110 Participants
Participants received AZD8529 40 mg capsule orally once daily for 13 weeks
|
|---|---|---|
|
Abstinence
|
10 Participants
|
11 Participants
|
Adverse Events
AZD8529 Low Dose
Serious events: 0 serious events
Other events: 74 other events
Deaths: 0 deaths
AZD8529 High Dose
Serious events: 3 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD8529 Low Dose
n=104 participants at risk
Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks
|
AZD8529 High Dose
n=110 participants at risk
Participants received AZD8529 40 mg capsule orally once daily for 13 weeks
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy with sponteneous abortion
|
0.00%
0/104
|
0.91%
1/110 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hidrandenitis
|
0.00%
0/104
|
0.91%
1/110 • Number of events 1
|
|
Endocrine disorders
Small cell lunch cancer
|
0.00%
0/104
|
0.91%
1/110 • Number of events 1
|
Other adverse events
| Measure |
AZD8529 Low Dose
n=104 participants at risk
Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks
|
AZD8529 High Dose
n=110 participants at risk
Participants received AZD8529 40 mg capsule orally once daily for 13 weeks
|
|---|---|---|
|
Nervous system disorders
Headache
|
13.5%
14/104 • Number of events 18
|
21.8%
24/110 • Number of events 36
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
6/104 • Number of events 9
|
10.0%
11/110 • Number of events 12
|
|
Infections and infestations
Upper respiratory tract infection
|
9.6%
10/104 • Number of events 10
|
16.4%
18/110 • Number of events 18
|
|
Psychiatric disorders
Insomnia
|
5.8%
6/104 • Number of events 6
|
6.4%
7/110 • Number of events 7
|
|
Investigations
Weight increased
|
2.9%
3/104 • Number of events 3
|
2.7%
3/110 • Number of events 3
|
|
General disorders
Fatigue
|
3.8%
4/104 • Number of events 4
|
5.5%
6/110 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
5/104 • Number of events 5
|
2.7%
3/110 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
5/104 • Number of events 5
|
1.8%
2/110 • Number of events 2
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.96%
1/104 • Number of events 3
|
1.8%
2/110 • Number of events 2
|
|
Metabolism and nutrition disorders
Pollakiuria
|
1.9%
2/104 • Number of events 2
|
3.6%
4/110 • Number of events 4
|
|
Eye disorders
Cataract
|
1.9%
2/104 • Number of events 2
|
0.91%
1/110 • Number of events 1
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/104
|
1.8%
2/110 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
3/104 • Number of events 3
|
0.00%
0/110
|
|
Vascular disorders
Hypertension
|
3.8%
4/104 • Number of events 4
|
0.91%
1/110 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
0.96%
1/104 • Number of events 1
|
0.00%
0/110
|
|
Cardiac disorders
Antrioventricular block first degree
|
0.96%
1/104 • Number of events 1
|
0.00%
0/110
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.96%
1/104 • Number of events 1
|
0.91%
1/110 • Number of events 1
|
|
Immune system disorders
Seasonal Allergy
|
1.9%
2/104 • Number of events 2
|
0.91%
1/110 • Number of events 1
|
|
Surgical and medical procedures
Dental care
|
0.00%
0/104
|
0.91%
1/110 • Number of events 1
|
|
Congenital, familial and genetic disorders
Colour blindness
|
0.96%
1/104 • Number of events 1
|
0.00%
0/110
|
|
Endocrine disorders
Hypothyroidism
|
0.96%
1/104 • Number of events 1
|
0.00%
0/110
|
|
Gastrointestinal disorders
Nausea
|
8.7%
9/104 • Number of events 11
|
9.1%
10/110 • Number of events 10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60