Economic Impact of Switching From Metoprolol to Nebivolol for Hypertension Treatment

Hypertension Clinical Trial

Official title:

Economic Impact of Switching From Metoprolol to Nebivolol for Hypertension Treatment: A Retrospective Database Analysis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01758263
• Other study ID #: NEB-HE-200
• Status: Active, not recruiting
• Phase: N/A
• First received: December 26, 2012
• Last updated: December 26, 2012
• Start date: October 2012
• Est. completion date: July 2013

Study information

• Verified date: December 2012
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Metoprolol
Metoprolol, oral administration
• Nebivolol
Nebivolol, oral administration

Locations

Country	Name	City	State
United States	Forest Investigative Site 0	Jersey City	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient monthly health care cost	The average per patient monthly health care cost for the pre-specified hypertensive target study population during the 6 months before and after switching from metoprolol to nebivolol	6 months	No
Secondary	Number of monthly out-patient visits	Estimate the average per patient monthly number of out-patient visits for the pre-specified hypertensive target study population during the 6 months before and after switching from metoprolol to nebivolol.	6 months	No
Secondary	Monthly Emergency Room visits per patient	Estimate of the average monthly number of Emergency Room (ER) visits per patient for the pre-specified hypertensive target study population during the 6 months before and after switching from metoprolol to nebivolol.	6 months	No
Secondary	Monthly hospitalizations per patient	Estimate of the average monthly number of hospitalizations per patient for the pre-specified hypertensive target study population during the 6 months before and after switching from metoprolol to nebivolol.	6 months	No