Economic Impact of Switching From Metoprolol to Nebivolol for Hypertension Treatment
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Hypertension |
| Intervention | Drug: Metoprolol Drug: Nebivolol |
| Phase | N/A |
| Sponsor | Forest Laboratories |
| Responsible Party | Forest Laboratories |
| ClinicalTrials.gov Identifier | NCT01758263 |
| First Received | December 26, 2012 |
| Last Updated | December 26, 2012 |
| Last verified | December 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 26, 2012 |
|---|---|
| Last Updated Date | December 26, 2012 |
| Start Date | October 2012 |
| Estimated Primary Completion Date | July 2013 |
| Current Primary Outcome Measures | Patient monthly health care cost [Time Frame: 6 months] [Designated as safety issue: No]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 |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Economic Impact of Switching From Metoprolol to Nebivolol for Hypertension Treatment |
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| Official Title | Economic Impact of Switching From Metoprolol to Nebivolol for Hypertension Treatment: A Retrospective Database Analysis |
| Brief 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. |
| Detailed Description | Not Provided |
| Study Type | Observational |
| Study Phase | N/A |
| Study Design | Observational Model: Cohort, Time Perspective: Retrospective |
| Condition | Hypertension |
| Intervention | Drug: Metoprolol Metoprolol, oral administration Drug: Nebivolol Nebivolol, oral administration |
| Study Arm (s) | Metoprolol to Nebivolol 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. |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
|---|---|
| Estimated Enrollment | 3000 |
| Estimated Completion Date | July 2013 |
| Estimated Primary Completion Date | December 2012 |
| Eligibility Criteria | 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01758263 |
|---|---|
| Other Study ID Numbers | NEB-HE-200 |
| Has Data Monitoring Committee | No |
| Information Provided By | Forest Laboratories |
| Study Sponsor | Forest Laboratories |
| Collaborators | Not Provided |
| Investigators | Study Director: Stephanie Chen, PhD Forest Laboratories |
| Verification Date | December 2012 |
Locations[ + expand ][ + ]
| Forest Investigative Site 0 | Jersey City, New Jersey, United States, 07311 |
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