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Economic Impact of Switching From Metoprolol to Nebivolol for Hypertension Treatment

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01758263
First received: December 26, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  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.


Condition Intervention
Hypertension
 Drug: Metoprolol
Drug: Nebivolol

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Economic Impact of Switching From Metoprolol to Nebivolol for Hypertension Treatment: A Retrospective Database Analysis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

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


Secondary Outcome Measures:
  • Number of monthly out-patient visits [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Monthly Emergency Room visits per patient [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Monthly hospitalizations per patient [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 3000
Study Start Date: October 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
 Drug: Metoprolol
Metoprolol, oral administration
Drug: Nebivolol
Nebivolol, oral administration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patents treated for hypertension during the period of 2007-2011 in the United States.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758263

Locations
United States, New Jersey
Forest Investigative Site 0
Jersey City, New Jersey, United States, 07311
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Stephanie Chen, PhD Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01758263     History of Changes
Other Study ID Numbers: NEB-HE-200
Study First Received: December 26, 2012
Last Updated: December 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
Hypertension
Health Care Cost
Monthly health care cost

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Nebivolol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
 Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on June 18, 2013