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To collect the efficacy and safety information of Eplerenone on patients with hypertension related to their appropriate use in daily practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eplerenone | Subjects who are treated with Eplerenone tablet for hypertension disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selara | Drug | Treatment should be initiated at 25 mg once daily and titrated to the recommended dose of 50 mg once daily, preferably within 4 weeks as tolerated by the patient. Selara may be administered with or without food. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 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. | 12 weeks |
| Number of Participants With 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure Over Time. | 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. | 12 weeks |
| Change in Diastolic Blood Pressure Over Time. |
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Inclusion Criteria:
Exclusion Criteria:
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The patients whom an investigator involving A6141113 prescribes the Selara tablet.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Selara | Participants taking Selara according to Japanese Package Insert. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Selara | Participants taking Selara according to Japanese Package Insert. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With 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. | No statistical analysis provided for the frequency of Treatment Related adverse events. | Posted | Number | participants | 12 weeks |
|
|
12 weeks
The frequency of treatment related adverse events during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Selara | Participants taking Selara according to Japanese Package Insert. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA-J 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes zoster | Infections and infestations | MedDRA-J 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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. |
| 12 weeks |
| Number of Participants That Responded to Selara Treatment. | Number of participants among the efficacy analysis population that responded to Selara treatment. | 12 weeks |
| No drug administration |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Number of Participants With 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. | No statistical analysis provided for the frequency of serious treatment related adverse events. | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | Change in Systolic Blood Pressure Over Time. | 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. | 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). | Posted | Mean | Standard Deviation | mmHg | 12 weeks |
|
|
|
|
| Secondary | Change in Diastolic Blood Pressure Over Time. | 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. | 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). | Posted | Mean | Standard Deviation | mmHg | 12 weeks |
|
|
|
|
| Secondary | Number of Participants That Responded to Selara Treatment. | Number of participants among the efficacy analysis population that responded to Selara treatment. | 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). | Posted | Number | participants | 12 weeks |
|
|
|
| 16 |
| 3,210 |
| 59 |
| 3,210 |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Drug interaction | General disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA-J 15.1 | Systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA-J 15.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Ear congestion | Ear and labyrinth disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA-J 15.1 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA-J 15.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA-J 15.1 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA-J 15.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA-J 15.1 | Systematic Assessment |
|
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.
The null hypothesis is that the mean systolic blood pressure at 8 weeks does not differ from that at baseline.
| t-test, 1 sided |
A one-sided paired t-test was performed to test the hypothesis. |
| <0.001 |
| 1-Sided |
| Superiority or Other (legacy) |
| The null hypothesis is that the mean systolic blood pressure at 12 weeks does not differ from that at baseline. | t-test, 1 sided | A one-sided paired t-test was performed to test the hypothesis. | <0.001 | 1-Sided | Superiority or Other (legacy) |
| The null hypothesis is that the mean systolic blood pressure at last evaluation date does not differ from that at baseline. | t-test, 1 sided | A one-sided paired t-test was performed to test the hypothesis. | <0.001 | 1-Sided | Superiority or Other (legacy) |
The null hypothesis is that the mean diastolic blood pressure at 8 weeks does not differ from that at baseline.
| t-test, 1 sided |
A one-sided paired t-test was performed to test the hypothesis. |
| <0.001 |
| 1-Sided |
| Superiority or Other (legacy) |
| The null hypothesis is that the mean diastolic blood pressure at 12 weeks does not differ from that at baseline. | t-test, 1 sided | A one-sided paired t-test was performed to test the hypothesis. | <0.001 | 1-Sided | Superiority or Other (legacy) |
| The null hypothesis is that the mean diastolic blood pressure at last evaluation date does not differ from that at baseline. | t-test, 1 sided | A one-sided paired t-test was performed to test the hypothesis. | <0.001 | 1-Sided | Superiority or Other (legacy) |