HypertensionNCT01758263
Economic Impact of Switching From Metoprolol to Nebivolol for Hypertension Treatment
An observational study of Hypertension, run by Forest Laboratories at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Metoprolol and Nebivolol
- Type of treatment
- Pill or oral medicine
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patents treated for hypertension during the period of 2007-2011 in the United States.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Forest Investigative Site 0
Jersey City, New Jersey, 07311
About this study
Official title: Economic Impact of Switching From Metoprolol to Nebivolol for Hypertension Treatment: A Retrospective Database Analysis
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.
- Conditions
- Hypertension
- Being tested
- Metoprolol, Nebivolol
- Keywords
- Hypertension, Health Care Cost, Monthly health care cost
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoprololDrug
Metoprolol, oral administration
NebivololDrug
Nebivolol, oral administration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Metoprolol; Drug: Nebivolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionDec 2012 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephanie Chen, PhD, Study director, Forest Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758263
- Sponsor's protocol ID
- NEB-HE-200
- Status last verified
- Dec 2012
- First submitted
- 26 Dec 2012
- Last updated
- 1 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Impact of Switching From Metoprolol to Nebivolol for Hypertension Treatment: A Retrospective Database Analysis
- ClinicalTrials.gov ID
- NCT01758263
- Acronym / sponsor ID
- NEB-HE-200
- Conditions
- Hypertension
- Keywords
- Hypertension, Health Care Cost, Monthly health care cost
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 1 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metoprolol to Nebivolol | – | Drug: Metoprolol, Drug: NebivololPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patents treated for hypertension during the period of 2007-2011 in the United States.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetoprololMetoprolol, oral administration | Drug | Metoprolol to Nebivolol |
| NebivololNebivolol, oral administration | Drug | Metoprolol to Nebivolol |
Primary outcome
Patient monthly health care cost
Time frame: 6 months
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Chen, PhD study director
Forest Laboratories
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Forest Laboratories at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient monthly health care cost (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2013.