Overview

This trial is active, not recruiting.

Condition hypertension
Treatments metoprolol, nebivolol
Sponsor Forest Laboratories
Start date October 2012
End date December 2012
Trial size 3000 participants
Trial identifier NCT01758263, NEB-HE-200

Summary

This is a retrospective data analysis of patients with high blood pressure (hypertension) who took metoprolol for a minimum of 6 months who then switched to taking nebivolol for a minimum of 6 month to treat hypertension. These patients will be identified from a large medical claims database. This study tests the hypothesis (alternative, higher or lower) that average patient monthly health care administrative cost changes after switching from metoprolol to nebivolol.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Patients with high blood pressure (hypertension) who were continuously treated with metoprolol for a minimum of 6 months prior to switching to nebivolol. Patients were then continuously treated with nebivolol for a minimum of 6 months.
metoprolol
Metoprolol, oral administration
nebivolol
Nebivolol, oral administration

Primary Outcomes

Measure
Patient monthly health care cost
time frame: 6 months

Secondary Outcomes

Measure
Number of monthly out-patient visits
time frame: 6 months
Monthly Emergency Room visits per patient
time frame: 6 months
Monthly hospitalizations per patient
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Be at least 18 years old at initiation of metoprolol (or first date on metoprolol treatment between 2007 and 2011) - Had one or more inpatient or outpatient claims with a primary or non-primary diagnosis of hypertension (ICD-9-CM 401.xx-405.xx) - Received nebivolol treatment continuously (defined as supply gap <30 days) for at least 6 months after initiation - Received metoprolol treatment continuously for at least 6 months prior to switching to (initiation of) nebivolol (defined as metoprolol was discontinued whereas a prescription for nebivolol was filled) - Had at least 12 months of continuous enrollment (as verified using enrollment file): 6 month prior to nebivolol initiation and 6 months following nebivolol initiation.

Additional Information

Official title Economic Impact of Switching From Metoprolol to Nebivolol for Hypertension Treatment: A Retrospective Database Analysis
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Forest Laboratories.