Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

NCT00749775 | Completed Results

• 1 other identifier: A6141113
• Study Type: observational
• Target: 3,338
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hypertension

Keywords

Eplerenone; Selara; Hypertension; Good post-marketing study Practice; Drug use Investigation; Regulatory Post Marketing Commitment Plan; ESSENCE

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Change in Systolic Blood Pressure Over Time.

  12 weeks

• Change in Diastolic Blood Pressure Over Time.

  12 weeks

• Number of Participants That Responded to Selara Treatment.

  12 weeks

Study Arms (1)

Eplerenone

Subjects who are treated with Eplerenone tablet for hypertension disease

Drug: Selara

Interventions

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.

Eplerenone

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients whom an investigator involving A6141113 prescribes the Selara tablet.

You may qualify if:

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

You may not qualify if:

• Subjects who have been prescribed Selara tablet.

Sponsors & Collaborators

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

Related Links

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

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 9, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 22, 2020
• Results First Posted: January 8, 2014

Record last verified: 2020-12