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Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan) (ESSENCE)

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ClinicalTrials.gov Identifier: NCT00749775
Recruitment Status : Completed
First Posted : September 9, 2008
Results First Posted : January 8, 2014
Last Update Posted : January 8, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Hypertension
Intervention Drug: Selara
Enrollment 3338
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Selara
Hide Arm/Group Description Participants taking Selara according to Japanese Package Insert.
Period Title: Overall Study
Started 3317
Completed 3210
Not Completed 107
Reason Not Completed
Protocol Violation             24
Lost to Follow-up             36
No visit after first day of treatment             44
No drug administration             3
Arm/Group Title Selara
Hide Arm/Group Description Participants taking Selara according to Japanese Package Insert.
Overall Number of Baseline Participants 3210
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3210 participants
<65 years old 1224
>=65 years old 1986
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3210 participants
Female
1539
  47.9%
Male
1671
  52.1%
1.Primary Outcome
Title Number of Participants With Treatment Related Adverse Events.
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No statistical analysis provided for the frequency of Treatment Related adverse events.
Arm/Group Title Selara
Hide Arm/Group Description:
Participants taking Selara according to Japanese Package Insert.
Overall Number of Participants Analyzed 3210
Measure Type: Number
Unit of Measure: participants
75
2.Primary Outcome
Title Number of Participants With Serious Treatment Related Adverse Events.
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No statistical analysis provided for the frequency of serious treatment related adverse events.
Arm/Group Title Selara
Hide Arm/Group Description:
Participants taking Selara according to Japanese Package Insert.
Overall Number of Participants Analyzed 3210
Measure Type: Number
Unit of Measure: participants
16
3.Secondary Outcome
Title Change in Systolic Blood Pressure Over Time.
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title At Baseline At 4 Weeks At 8 Weeks At 12 Weeks At Last Evaluation Date
Hide Arm/Group Description:
Mean systolic blood pressure at baseline among Participants taking Selara according to Japanese Package Insert.
Mean systolic blood pressure at 4 weeks among Participants taking Selara according to Japanese Package Insert.
Mean systolic blood pressure at 8 weeks among Participants taking Selara according to Japanese Package Insert.
Mean systolic blood pressure at 12 weeks among Participants taking Selara according to Japanese Package Insert.
Mean systolic blood pressure at last evaluation date among Participants taking Selara according to Japanese Package Insert.
Overall Number of Participants Analyzed 2252 880 756 730 2150
Mean (Standard Deviation)
Unit of Measure: mmHg
151.8  (19.6) 140.7  (17.7) 137.5  (16.2) 134.7  (15.6) 134.0  (15.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection At Baseline, At 4 Weeks
Comments The null hypothesis is that the mean systolic blood pressure at 4 weeks does not differ from that at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments A one-sided paired t-test was performed to test the hypothesis.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection At Baseline, At 8 Weeks
Comments The null hypothesis is that the mean systolic blood pressure at 8 weeks does not differ from that at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments A one-sided paired t-test was performed to test the hypothesis.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection At Baseline, At 12 Weeks
Comments The null hypothesis is that the mean systolic blood pressure at 12 weeks does not differ from that at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments A one-sided paired t-test was performed to test the hypothesis.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection At Baseline, At Last Evaluation Date
Comments The null hypothesis is that the mean systolic blood pressure at last evaluation date does not differ from that at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments A one-sided paired t-test was performed to test the hypothesis.
4.Secondary Outcome
Title Change in Diastolic Blood Pressure Over Time.
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title At Baseline At 4 Weeks At 8 Weeks At 12 Weeks At Last Evaluation Date
Hide Arm/Group Description:
Mean diastolic blood pressure at baseline among Participants taking Selara according to Japanese Package Insert.
Mean diastolic blood pressure at 4 weeks among Participants taking Selara according to Japanese Package Insert.
Mean diastolic blood pressure at 8 weeks among Participants taking Selara according to Japanese Package Insert.
Mean diastolic blood pressure at 12 weeks among Participants taking Selara according to Japanese Package Insert.
Mean diastolic blood pressure at last evaluation date among Participants taking Selara according to Japanese Package Insert.
Overall Number of Participants Analyzed 2252 880 756 730 2150
Mean (Standard Deviation)
Unit of Measure: mmHg
85.1  (13.9) 79.5  (12.9) 78.0  (12.5) 76.6  (11.8) 77.0  (11.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection At Baseline, At 4 Weeks
Comments The null hypothesis is that the mean diastolic blood pressure at 4 weeks does not differ from that at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments A one-sided paired t-test was performed to test the hypothesis.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection At Baseline, At 8 Weeks
Comments The null hypothesis is that the mean diastolic blood pressure at 8 weeks does not differ from that at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments A one-sided paired t-test was performed to test the hypothesis.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection At Baseline, At 12 Weeks
Comments The null hypothesis is that the mean diastolic blood pressure at 12 weeks does not differ from that at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments A one-sided paired t-test was performed to test the hypothesis.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection At Baseline, At Last Evaluation Date
Comments The null hypothesis is that the mean diastolic blood pressure at last evaluation date does not differ from that at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments A one-sided paired t-test was performed to test the hypothesis.
5.Secondary Outcome
Title Number of Participants That Responded to Selara Treatment.
Hide Description Number of participants among the efficacy analysis population that responded to Selara treatment.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Selara
Hide Arm/Group Description:
Participants taking Selara according to Japanese Package Insert.
Overall Number of Participants Analyzed 3009
Measure Type: Number
Unit of Measure: participants
2772
Time Frame 12 weeks
Adverse Event Reporting Description The frequency of treatment related adverse events during the study.
 
Arm/Group Title Selara
Hide Arm/Group Description Participants taking Selara according to Japanese Package Insert.
All-Cause Mortality
Selara
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Selara
Affected / at Risk (%) # Events
Total   16/3210 (0.50%)    
General disorders   
Drug interaction  1  1/3210 (0.03%)  1
Hepatobiliary disorders   
Hepatic function abnormal  1  1/3210 (0.03%)  1
Investigations   
Blood potassium increased  1  2/3210 (0.06%)  2
Metabolism and nutrition disorders   
Hyperkalaemia  1  9/3210 (0.28%)  9
Decreased appetite  1  1/3210 (0.03%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acute myeloid leukaemia  1  1/3210 (0.03%)  1
Renal and urinary disorders   
Renal impairment  1  3/3210 (0.09%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA-J 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Selara
Affected / at Risk (%) # Events
Total   59/3210 (1.84%)    
Blood and lymphatic system disorders   
Lymphadenitis  1  1/3210 (0.03%)  1
Cardiac disorders   
Palpitations  1  1/3210 (0.03%)  1
Ear and labyrinth disorders   
Ear congestion  1  1/3210 (0.03%)  1
Gastrointestinal disorders   
Nausea  1  3/3210 (0.09%)  3
Gastric ulcer  1  1/3210 (0.03%)  1
Diarrhoea  1  1/3210 (0.03%)  1
Faecal incontinence  1  1/3210 (0.03%)  1
General disorders   
Malaise  1  1/3210 (0.03%)  1
Oedema  1  1/3210 (0.03%)  1
Oedema peripheral  1  1/3210 (0.03%)  1
Hepatobiliary disorders   
Liver disorder  1  1/3210 (0.03%)  1
Infections and infestations   
Herpes zoster  1  1/3210 (0.03%)  1
Investigations   
Blood pressure decreased  1  1/3210 (0.03%)  1
Blood potassium increased  1  4/3210 (0.12%)  4
Blood creatinine increased  1  2/3210 (0.06%)  2
Blood cholesterol increased  1  1/3210 (0.03%)  1
Blood urea increased  1  1/3210 (0.03%)  1
Metabolism and nutrition disorders   
Hyperkalaemia  1  11/3210 (0.34%)  11
Hyperuricaemia  1  1/3210 (0.03%)  1
Dehydration  1  1/3210 (0.03%)  1
Hyponatraemia  1  2/3210 (0.06%)  2
Nervous system disorders   
Hypoaesthesia  1  1/3210 (0.03%)  1
Headache  1  1/3210 (0.03%)  1
Dizziness  1  7/3210 (0.22%)  7
Convulsion  1  1/3210 (0.03%)  1
Renal and urinary disorders   
Renal impairment  1  4/3210 (0.12%)  4
Polyuria  1  1/3210 (0.03%)  1
Pollakiuria  1  1/3210 (0.03%)  1
Nocturia  1  1/3210 (0.03%)  1
Respiratory, thoracic and mediastinal disorders   
Pharyngeal oedema  1  1/3210 (0.03%)  1
Skin and subcutaneous tissue disorders   
Photosensitivity reaction  1  1/3210 (0.03%)  1
Rash  1  3/3210 (0.09%)  3
Drug eruption  1  1/3210 (0.03%)  1
Vascular disorders   
Orthostatic hypotension  1  1/3210 (0.03%)  1
Hypotension  1  2/3210 (0.06%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA-J 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00749775     History of Changes
Other Study ID Numbers: A6141113
First Submitted: September 5, 2008
First Posted: September 9, 2008
Results First Submitted: November 20, 2013
Results First Posted: January 8, 2014
Last Update Posted: January 8, 2014