HypertensionPhase 3NCT00547300

Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-release (ER) for Hypertension

A Phase 3 study testing Metoprolol ER and Nebivolol in people with Hypertension, run by Forest Laboratories at 24 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study was to compare the tolerability of nebivolol to metoprolol ER in a general population of patients with mild to moderate hypertension receiving hydrochlorothiazide (HCTZ) Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Hypertension
What is being tested?: Metoprolol ER and Nebivolol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 24 sitesUnited States
Study dates: 31 Oct 2007to 2 Jan 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, ambulatory outpatients
History of hypertension being treated with two medications, one of which must be HCTZ and the other of which must not be a beta-blocker or clonidine
SBP of 135-155 mm Hg and/or DBP of >85 mm Hg at screening (Visit 1)
SBP of 140-165 mm Hg and DBP > 90 mmHg at randomization (Visit 3)

Who cannot join

Treatment with a beta-blocker or clonidine within 6 months of screening (Visit 1)
Clinically significant respiratory disease (e.g., bronchial asthma, reactive airways disease, chronic obstructive pulmonary disease)
Coronary artery disease requiring treatment with a calcium channel blocker or nitrates
Clinically significant cardiovascular disease (e.g., myocardial infarction, cerebrovascular event, significant arrhythmia) within 6 months of screening (Visit 1)
History of severe mental illness (including Major Depressive Disorder, psychosis, dementia, bipolar disorder) within 6 months of screening (Visit 1)
Use of antipsychotic medication (e.g., dopamine receptor antagonists, serotonin dopamine receptor antagonists) or antidepressants

Show all 10Show fewer

Diabetes mellitus, type I or II
Participation in a previous investigational study of nebivolol at any time
Receipt of treatment with an investigational study drug within 30 days of screening (Visit 1)
History of hypersensitivity to nebivolol, metoprolol ER, other beta-blockers, HCTZ, or other sulfonamide-derived drugs

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

Forest Research Institute 009
Atlanta, Georgia, 30338
Forest Research Institute 028
Beverly Hills, California, 90211
Forest Research Institute 014
Birmingham, Alabama, 35205
Forest Research Institute 040
Bountiful, Utah, 84010
Forest Research Institute 003
Carrollton, Texas, 75006
Forest Investigative Site 002
Charleston, South Carolina, 29407
Forest Research Institute 010
DeLand, Florida, 32720
Forest Research Institute 054
Encinitas, California, 92024
Forest Research Institute 032
Greenville, South Carolina, 29615
Forest Research Institute 019
Holly Hill, Florida, 32117
Forest Research Institute 036
Hollywood, Florida, 33023
Forest Research Institute 027
Las Vegas, Nevada, 89106
Forest Research Institute 008
Nashville, Tennessee, 37203
Forest Research Institute 006
Oxon Hill, Maryland, 20745
Forest Research Institute 007
Pembroke Pines, Florida, 33024
Forest Research Institute 025
Roseville, California, 95661
Forest Research Institute 050
Salisbury, North Carolina, 28144
Forest Research Institute 012
San Antonio, Texas, 78229
Forest Research Institute 048
Sugar Land, Texas, 77479
Forest Research Institute 013
Tustin, California, 92780
Forest Research Institute 053
Vista, California, 92083
Forest Research Institute 052
Walnut Creek, California, 94598
Forest Research Institute 033
Westlake Village, California, 91361
Forest Research Institute 039
Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: Tolerability of Nebivolol Compared With Metoprolol ER in Patients With Mild to Moderate Hypertension Taking Hydrochlorothiazide (HCTZ)

The purpose of this study was to compare the tolerability of nebivolol to metoprolol ER in a general population of patients with mild to moderate hypertension receiving hydrochlorothiazide (HCTZ)

Read the detailed description

This study was an 18-week study to evaluate the tolerability of nebivolol compared to metoprolol ER in outpatients with mild to moderate hypertension taking HCTZ. It is a multi-center, randomized, double blind (DB), active-control, parallel-group study, starting with a 4-week HCTZ run-in phase, followed by a 12-week DB treatment phase. Patients meeting the entry criteria at the end of run-in are randomized to one of two treatment groups, nebivolol or metoprolol ER. Up-titration of dose of study drug will occur if needed during the first 4 weeks of the DB phase, after which there is an 8-week stable-dose period of treatment. A 2-week double-blind withdrawal phase follows, during which tapering off study drug occurs.

Conditions: Hypertension
Being tested: Metoprolol ER, Nebivolol
Keywords: Hypertension, Nebivolol, Beta blocker, Tolerability
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Metoprolol ERDrug
Metoprolol ER once daily, oral administration
NebivololDrug
Nebivolol once daily, oral administration

Study groups in NCT00547300
Study group	Role	What they receive
Nebivolol	Experimental	Nebivolol 5 mg, 10 mg or 20 mg Receives: Drug: Nebivolol
Metoprolol ER	Active comparator	Metoprolol ER 50 mg, 100 mg or 200 mg Receives: Drug: Metoprolol ER

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score
The PSQ contained 44 possible symptoms rated from 0 (no discomfort) to 5 (extreme discomfort).
Measured: Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12)

Secondary outcomes (2)

Peripheral Blood Pressure (BP)
Measured: Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)
Pulse Rate
Measured: Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Oct 20072 Jan 2008

First posted22 Oct 2007 (estimated)
Study start31 Oct 2007
Primary completion2 Jan 2008
Study completion2 Jan 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00547300
Sponsor's protocol ID: NEB-MD-03
Status last verified: Apr 2019
First submitted: 19 Oct 2007
Last updated: 21 May 2019
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tolerability of Nebivolol Compared With Metoprolol ER in Patients With Mild to Moderate Hypertension Taking Hydrochlorothiazide (HCTZ)
ClinicalTrials.gov ID: NCT00547300
Acronym / sponsor ID: NEB-MD-03
Conditions: Hypertension
Keywords: Hypertension, Nebivolol, Beta blocker, Tolerability
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 49 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Collaborators: Mylan Laboratories
Study start: 31 Oct 2007 (actual)
Primary completion: 2 Jan 2008 (actual)
Study completion: 2 Jan 2008 (actual)
First posted: 22 Oct 2007 (estimated)
Results: Posted 21 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study was to compare the tolerability of nebivolol to metoprolol ER in a general population of patients with mild to moderate hypertension receiving hydrochlorothiazide (HCTZ)

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Nebivolol	Experimental	Drug: NebivololNebivolol 5 mg, 10 mg or 20 mg
Metoprolol ER	Active comparator	Drug: Metoprolol ERMetoprolol ER 50 mg, 100 mg or 200 mg

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female, ambulatory outpatients
History of hypertension being treated with two medications, one of which must be HCTZ and the other of which must not be a beta-blocker or clonidine
SBP of 135-155 mm Hg and/or DBP of >85 mm Hg at screening (Visit 1)
SBP of 140-165 mm Hg and DBP > 90 mmHg at randomization (Visit 3)

Key exclusion criteria (10 listed)

Treatment with a beta-blocker or clonidine within 6 months of screening (Visit 1)
Clinically significant respiratory disease (e.g., bronchial asthma, reactive airways disease, chronic obstructive pulmonary disease)
Coronary artery disease requiring treatment with a calcium channel blocker or nitrates
Clinically significant cardiovascular disease (e.g., myocardial infarction, cerebrovascular event, significant arrhythmia) within 6 months of screening (Visit 1)
History of severe mental illness (including Major Depressive Disorder, psychosis, dementia, bipolar disorder) within 6 months of screening (Visit 1)

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
Metoprolol ERMetoprolol ER once daily, oral administration	Drug	Metoprolol ER
NebivololNebivolol once daily, oral administration	Drug	Nebivolol

Primary outcome

Change From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score
Time frame: Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12)
The PSQ contained 44 possible symptoms rated from 0 (no discomfort) to 5 (extreme discomfort).

2 secondary outcomes

Peripheral Blood Pressure (BP)
Time frame: Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)
Pulse Rate
Time frame: Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)

Results and safety

Results posted to the registry on 21 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nebivolol	25	0
Metoprolol Extended-Release (ER)	26	0

Primary outcome: Change From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score

Time frame: Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12)

Population analysed: Formal analysis of the primary endpoint was not conducted in this abbreviated study as the study was terminated before visit 10 was reached.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Event data was collected over a four month period from October 2007 to January 2008.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nebivolol	0 of 25 (0%)	5 of 25 (20%)	0 of 25
Metoprolol Extended-Release (ER)	0 of 26 (0%)	3 of 24 (12.5%)	0 of 26

Limitations and caveats (from the sponsor): Study was terminated early due to administrative reasons. Formal analyses of primary and secondary endpoints were not conducted in this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.

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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.

The record lists no contact. Use the official record to reach the sponsor.

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metoprolol ER and Nebivolol in people with Hypertension, run by Forest Laboratories at 24 sites 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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score (time frame: Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00547300.

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 21 May 2019.