An observational study in Hypertension, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed. Per ClinicalTrials.gov, last updated 2020-12-22.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Observational
To collect the efficacy and safety information of Eplerenone on patients with hypertension related to their appropriate use in daily practice.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 3,338 is above the median of 210 across 1,359 observational studies indexed under Hypertension.
Browse Hypertension studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
The patients whom an investigator involving A6141113 prescribes the Selara tablet.
Exclusion Criteria:
Subjects who are treated with Eplerenone tablet for hypertension disease
Drug: Selara
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.
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.
Time frame: 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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
Number of Participants That Responded to Selara Treatment.
Number of participants among the efficacy analysis population that responded to Selara treatment.
Time frame: 12 weeks
| Milestone | Selara |
|---|---|
| Started | 3317 |
| Completed | 3210 |
| Not completed | 107 |
| Withdrew: Protocol violation | 24 |
| Withdrew: Lost to follow-up | 36 |
| Withdrew: No visit after first day of treatment | 44 |
| Withdrew: No drug administration | 3 |
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.
| participants | Selara |
|---|---|
| Number of Participants With Treatment Related Adverse Events. | 75 |
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.
| participants | Selara |
|---|---|
| Number of Participants With Serious Treatment Related Adverse Events. | 16 |
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.
| mmHg | At Baseline | At 4 Weeks | At 8 Weeks | At 12 Weeks | At Last Evaluation Date |
|---|---|---|---|---|---|
| Change in Systolic Blood Pressure Over Time. | 151.8 ± 19.6 | 140.7 ± 17.7 | 137.5 ± 16.2 | 134.7 ± 15.6 | 134.0 ± 15.9 |
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.
| mmHg | At Baseline | At 4 Weeks | At 8 Weeks | At 12 Weeks | At Last Evaluation Date |
|---|---|---|---|---|---|
| Change in Diastolic Blood Pressure Over Time. | 85.1 ± 13.9 | 79.5 ± 12.9 | 78.0 ± 12.5 | 76.6 ± 11.8 | 77.0 ± 11.7 |
Number of participants among the efficacy analysis population that responded to Selara treatment.
| participants | Selara |
|---|---|
| Number of Participants That Responded to Selara Treatment. | 2772 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Selara | — | 16/3,210 (0.5%) | 59/3,210 (1.8%) |
| Event | Selara |
|---|---|
| HyperkalaemiaMetabolism and nutrition disorders | 9/3210 |
| Renal impairmentRenal and urinary disorders | 3/3210 |
| Blood potassium increasedInvestigations | 2/3210 |
| Acute myeloid leukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/3210 |
| Decreased appetiteMetabolism and nutrition disorders | 1/3210 |
| Hepatic function abnormalHepatobiliary disorders | 1/3210 |
| Drug interactionGeneral disorders | 1/3210 |
| Event | Selara |
|---|---|
| HyperkalaemiaMetabolism and nutrition disorders | 11/3210 |
| DizzinessNervous system disorders | 7/3210 |
| Renal impairmentRenal and urinary disorders | 4/3210 |
| Blood potassium increasedInvestigations | 4/3210 |
| NauseaGastrointestinal disorders | 3/3210 |
| RashSkin and subcutaneous tissue disorders | 3/3210 |
| HyponatraemiaMetabolism and nutrition disorders | 2/3210 |
| HypotensionVascular disorders | 2/3210 |
| Blood creatinine increasedInvestigations | 2/3210 |
| Herpes zosterInfections and infestations | 1/3210 |
| Age, Customized(participants) | Selara |
|---|---|
| <65 years old | 1224 |
| >=65 years old | 1986 |
| Sex: Female, Male(Participants) | Selara |
|---|---|
| Female | 1539 |
| Male | 1671 |
No study locations are listed for this record.
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.