Trial Outcomes & Findings for Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan) (NCT NCT00749775)
NCT ID: NCT00749775
Last Updated: 2020-12-22
Results Overview
Adverse events mean all unfavorable events that occur in participants after administration of Selara, irrespective of causal relationship to Selara (including clinically problematic abnormal changes in laboratory test values). Treatment Related Adverse Events were evaluated in company with the causal relationship to Selara.
Recruitment status
COMPLETED
Target enrollment
3338 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-12-22
Participant Flow
Participant milestones
| Measure |
Selara
Participants taking Selara according to Japanese Package Insert.
|
|---|---|
|
Overall Study
STARTED
|
3317
|
|
Overall Study
COMPLETED
|
3210
|
|
Overall Study
NOT COMPLETED
|
107
|
Reasons for withdrawal
| Measure |
Selara
Participants taking Selara according to Japanese Package Insert.
|
|---|---|
|
Overall Study
Protocol Violation
|
24
|
|
Overall Study
Lost to Follow-up
|
36
|
|
Overall Study
No visit after first day of treatment
|
44
|
|
Overall Study
No drug administration
|
3
|
Baseline Characteristics
Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Baseline characteristics by cohort
| Measure |
Selara
n=3210 Participants
Participants taking Selara according to Japanese Package Insert.
|
|---|---|
|
Age, Customized
<65 years old
|
1224 participants
n=5 Participants
|
|
Age, Customized
>=65 years old
|
1986 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1539 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1671 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: No statistical analysis provided for the frequency of Treatment Related adverse events.
Adverse events mean all unfavorable events that occur in participants after administration of Selara, irrespective of causal relationship to Selara (including clinically problematic abnormal changes in laboratory test values). Treatment Related Adverse Events were evaluated in company with the causal relationship to Selara.
Outcome measures
| Measure |
Selara
n=3210 Participants
Participants taking Selara according to Japanese Package Insert.
|
At 4 Weeks
Mean systolic blood pressure at 4 weeks among Participants taking Selara according to Japanese Package Insert.
|
At 8 Weeks
Mean systolic blood pressure at 8 weeks among Participants taking Selara according to Japanese Package Insert.
|
At 12 Weeks
Mean systolic blood pressure at 12 weeks among Participants taking Selara according to Japanese Package Insert.
|
At Last Evaluation Date
Mean systolic blood pressure at last evaluation date among Participants taking Selara according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Related Adverse Events.
|
75 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: No statistical analysis provided for the frequency of serious treatment related adverse events.
Serious treatment related adverse events mean those that may lead to death, life-threatening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anomaly/congenital deficiency, or other medically significant events or disorder.
Outcome measures
| Measure |
Selara
n=3210 Participants
Participants taking Selara according to Japanese Package Insert.
|
At 4 Weeks
Mean systolic blood pressure at 4 weeks among Participants taking Selara according to Japanese Package Insert.
|
At 8 Weeks
Mean systolic blood pressure at 8 weeks among Participants taking Selara according to Japanese Package Insert.
|
At 12 Weeks
Mean systolic blood pressure at 12 weeks among Participants taking Selara according to Japanese Package Insert.
|
At Last Evaluation Date
Mean systolic blood pressure at last evaluation date among Participants taking Selara according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Number of Participants With Serious Treatment Related Adverse Events.
|
16 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately).
The primary analysis item was the mean systolic blood pressure at 4, 8, and 12 weeks of the observation period or at last evaluation date if Selara was terminated prematurely.
Outcome measures
| Measure |
Selara
n=2252 Participants
Participants taking Selara according to Japanese Package Insert.
|
At 4 Weeks
n=880 Participants
Mean systolic blood pressure at 4 weeks among Participants taking Selara according to Japanese Package Insert.
|
At 8 Weeks
n=756 Participants
Mean systolic blood pressure at 8 weeks among Participants taking Selara according to Japanese Package Insert.
|
At 12 Weeks
n=730 Participants
Mean systolic blood pressure at 12 weeks among Participants taking Selara according to Japanese Package Insert.
|
At Last Evaluation Date
n=2150 Participants
Mean systolic blood pressure at last evaluation date among Participants taking Selara according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Change in Systolic Blood Pressure Over Time.
|
151.8 mmHg
Standard Deviation 19.6
|
140.7 mmHg
Standard Deviation 17.7
|
137.5 mmHg
Standard Deviation 16.2
|
134.7 mmHg
Standard Deviation 15.6
|
134.0 mmHg
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately).
The primary analysis item was the mean diastolic blood pressure at 4, 8, and 12 weeks of the observation period or at last evaluation date if Selara was terminated prematurely.
Outcome measures
| Measure |
Selara
n=2252 Participants
Participants taking Selara according to Japanese Package Insert.
|
At 4 Weeks
n=880 Participants
Mean systolic blood pressure at 4 weeks among Participants taking Selara according to Japanese Package Insert.
|
At 8 Weeks
n=756 Participants
Mean systolic blood pressure at 8 weeks among Participants taking Selara according to Japanese Package Insert.
|
At 12 Weeks
n=730 Participants
Mean systolic blood pressure at 12 weeks among Participants taking Selara according to Japanese Package Insert.
|
At Last Evaluation Date
n=2150 Participants
Mean systolic blood pressure at last evaluation date among Participants taking Selara according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Change in Diastolic Blood Pressure Over Time.
|
85.1 mmHg
Standard Deviation 13.9
|
79.5 mmHg
Standard Deviation 12.9
|
78.0 mmHg
Standard Deviation 12.5
|
76.6 mmHg
Standard Deviation 11.8
|
77.0 mmHg
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately).
Number of participants among the efficacy analysis population that responded to Selara treatment.
Outcome measures
| Measure |
Selara
n=3009 Participants
Participants taking Selara according to Japanese Package Insert.
|
At 4 Weeks
Mean systolic blood pressure at 4 weeks among Participants taking Selara according to Japanese Package Insert.
|
At 8 Weeks
Mean systolic blood pressure at 8 weeks among Participants taking Selara according to Japanese Package Insert.
|
At 12 Weeks
Mean systolic blood pressure at 12 weeks among Participants taking Selara according to Japanese Package Insert.
|
At Last Evaluation Date
Mean systolic blood pressure at last evaluation date among Participants taking Selara according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Number of Participants That Responded to Selara Treatment.
|
2772 participants
|
—
|
—
|
—
|
—
|
Adverse Events
Selara
Serious events: 16 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Selara
n=3210 participants at risk
Participants taking Selara according to Japanese Package Insert.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.28%
9/3210 • Number of events 9 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Renal and urinary disorders
Renal impairment
|
0.09%
3/3210 • Number of events 3 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
General disorders
Drug interaction
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Investigations
Blood potassium increased
|
0.06%
2/3210 • Number of events 2 • 12 weeks
The frequency of treatment related adverse events during the study.
|
Other adverse events
| Measure |
Selara
n=3210 participants at risk
Participants taking Selara according to Japanese Package Insert.
|
|---|---|
|
Infections and infestations
Herpes zoster
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.34%
11/3210 • Number of events 11 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.06%
2/3210 • Number of events 2 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Nervous system disorders
Headache
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Nervous system disorders
Dizziness
|
0.22%
7/3210 • Number of events 7 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Nervous system disorders
Convulsion
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Cardiac disorders
Palpitations
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Vascular disorders
Orthostatic hypotension
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Vascular disorders
Hypotension
|
0.06%
2/3210 • Number of events 2 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.09%
3/3210 • Number of events 3 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Hepatobiliary disorders
Liver disorder
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.09%
3/3210 • Number of events 3 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Renal and urinary disorders
Renal impairment
|
0.12%
4/3210 • Number of events 4 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Renal and urinary disorders
Polyuria
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Renal and urinary disorders
Pollakiuria
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Renal and urinary disorders
Nocturia
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
General disorders
Malaise
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
General disorders
Oedema
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
General disorders
Oedema peripheral
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Investigations
Blood pressure decreased
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Investigations
Blood potassium increased
|
0.12%
4/3210 • Number of events 4 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Investigations
Blood creatinine increased
|
0.06%
2/3210 • Number of events 2 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Investigations
Blood cholesterol increased
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
|
Investigations
Blood urea increased
|
0.03%
1/3210 • Number of events 1 • 12 weeks
The frequency of treatment related adverse events during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER