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

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00749775
• Collaborator: (none)
• Enrollment: 3,338
• Duration (Months): 54

Study Details

Study Description

Brief Summary

To collect the efficacy and safety information of Eplerenone on patients with hypertension related to their appropriate use in daily practice.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Selara

Study Design

• Study Type: Observational
• Actual Enrollment: 3338 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Eplerenone Observational Study Of Safety And Efficacy Evaluation To Normalize Blood Pressure For Clinical Effectiveness
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Eplerenone 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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment Related Adverse Events. [12 weeks]

   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.

2. Number of Participants With Serious Treatment Related Adverse Events. [12 weeks]

   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.

Secondary Outcome Measures

1. Change in Systolic Blood Pressure Over Time. [12 weeks]

   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.

2. Change in Diastolic Blood Pressure Over Time. [12 weeks]

   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.

3. Number of Participants That Responded to Selara Treatment. [12 weeks]

   Number of participants among the efficacy analysis population that responded to Selara treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or Female patients who are prescribed Selara tablet for Hypertension.

Exclusion Criteria:

• Subjects who have been prescribed Selara tablet.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00749775
• Other Study ID Numbers: A6141113
• First Posted: Sep 9, 2008
• Last Update Posted: Dec 22, 2020
• Last Verified: Dec 1, 2020

• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: Eplerenone; Selara; Hypertension; Good post-marketing study Practice; Drug use Investigation; Regulatory Post Marketing Commitment Plan; ESSENCE
• Additional relevant MeSH terms: Hypertension

Study Results

Participant Flow

Arm/Group Title	Selara
Arm/Group Description	Participants taking Selara according to Japanese Package Insert.
Period Title: Overall Study
STARTED	3317
COMPLETED	3210
NOT COMPLETED	107

Baseline Characteristics

Arm/Group Title	Selara
Arm/Group Description	Participants taking Selara according to Japanese Package Insert.
Overall Participants	3210
Age, Customized (participants) [Number]
<65 years old	1224 38.1%
>=65 years old	1986 61.9%
Sex: Female, Male (Count of Participants)
Female	1539 47.9%
Male	1671 52.1%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment Related Adverse Events.
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

Outcome Measure Data

Analysis Population Description

No statistical analysis provided for the frequency of Treatment Related adverse events.

Arm/Group Title	Selara
Arm/Group Description	Participants taking Selara according to Japanese Package Insert.
Measure Participants	3210
Number [participants]	75 2.3%

2. Primary Outcome

Title	Number of Participants With Serious Treatment Related Adverse Events.
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

Outcome Measure Data

Analysis Population Description

No statistical analysis provided for the frequency of serious treatment related adverse events.

Arm/Group Title	Selara
Arm/Group Description	Participants taking Selara according to Japanese Package Insert.
Measure Participants	3210
Number [participants]	16 0.5%

3. Secondary Outcome

Title	Change in Systolic Blood Pressure Over Time.
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

Outcome Measure Data

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
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.
Measure Participants	2252	880	756	730	2150
Mean (Standard Deviation) [mmHg]	151.8 (19.6)	140.7 (17.7)	137.5 (16.2)	134.7 (15.6)	134.0 (15.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Selara, 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 (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Selara, 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 (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Selara, 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 (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Selara, 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 (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	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.
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

Outcome Measure Data

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
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.
Measure Participants	2252	880	756	730	2150
Mean (Standard Deviation) [mmHg]	85.1 (13.9)	79.5 (12.9)	78.0 (12.5)	76.6 (11.8)	77.0 (11.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Selara, 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 (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Selara, 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 (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Selara, 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 (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 1 sided
	Comments	A one-sided paired t-test was performed to test the hypothesis.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Selara, 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 (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	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.
Description	Number of participants among the efficacy analysis population that responded to Selara treatment.
Time Frame	12 weeks

Outcome Measure Data

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
Arm/Group Description	Participants taking Selara according to Japanese Package Insert.
Measure Participants	3009
Number [participants]	2772 86.4%

Adverse Events

Time Frame	12 weeks
Adverse Event Reporting Description	The frequency of treatment related adverse events during the study.
Arm/Group Title	Selara
Arm/Group Description	Participants taking Selara according to Japanese Package Insert.
All Cause Mortality
	Selara
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Selara
	Affected / at Risk (%)	# Events
Total	16/3210 (0.5%)
General disorders
Drug interaction	1/3210 (0%)	1
Hepatobiliary disorders
Hepatic function abnormal	1/3210 (0%)	1
Investigations
Blood potassium increased	2/3210 (0.1%)	2
Metabolism and nutrition disorders
Hyperkalaemia	9/3210 (0.3%)	9
Decreased appetite	1/3210 (0%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia	1/3210 (0%)	1
Renal and urinary disorders
Renal impairment	3/3210 (0.1%)	3
Other (Not Including Serious) Adverse Events
	Selara
	Affected / at Risk (%)	# Events
Total	59/3210 (1.8%)
Blood and lymphatic system disorders
Lymphadenitis	1/3210 (0%)	1
Cardiac disorders
Palpitations	1/3210 (0%)	1
Ear and labyrinth disorders
Ear congestion	1/3210 (0%)	1
Gastrointestinal disorders
Nausea	3/3210 (0.1%)	3
Gastric ulcer	1/3210 (0%)	1
Diarrhoea	1/3210 (0%)	1
Faecal incontinence	1/3210 (0%)	1
General disorders
Malaise	1/3210 (0%)	1
Oedema	1/3210 (0%)	1
Oedema peripheral	1/3210 (0%)	1
Hepatobiliary disorders
Liver disorder	1/3210 (0%)	1
Infections and infestations
Herpes zoster	1/3210 (0%)	1
Investigations
Blood pressure decreased	1/3210 (0%)	1
Blood potassium increased	4/3210 (0.1%)	4
Blood creatinine increased	2/3210 (0.1%)	2
Blood cholesterol increased	1/3210 (0%)	1
Blood urea increased	1/3210 (0%)	1
Metabolism and nutrition disorders
Hyperkalaemia	11/3210 (0.3%)	11
Hyperuricaemia	1/3210 (0%)	1
Dehydration	1/3210 (0%)	1
Hyponatraemia	2/3210 (0.1%)	2
Nervous system disorders
Hypoaesthesia	1/3210 (0%)	1
Headache	1/3210 (0%)	1
Dizziness	7/3210 (0.2%)	7
Convulsion	1/3210 (0%)	1
Renal and urinary disorders
Renal impairment	4/3210 (0.1%)	4
Polyuria	1/3210 (0%)	1
Pollakiuria	1/3210 (0%)	1
Nocturia	1/3210 (0%)	1
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema	1/3210 (0%)	1
Skin and subcutaneous tissue disorders
Photosensitivity reaction	1/3210 (0%)	1
Rash	3/3210 (0.1%)	3
Drug eruption	1/3210 (0%)	1
Vascular disorders
Orthostatic hypotension	1/3210 (0%)	1
Hypotension	2/3210 (0.1%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.