A Phase 3 interventional study of Metoprolol ER and Nebivolol in Hypertension, sponsored by Forest Laboratories. Terminated at 24 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-05-21.
Sponsored by Forest Laboratories · Phase 3, Interventional, and Treatment
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)
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.
6,689 studies on the registry are indexed under Hypertension; 964 are open to participants now.
This study's enrollment of 49 is below the median of 90 across 4,994 interventional studies indexed under Hypertension.
Browse Hypertension studies →Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nebivolol 5 mg, 10 mg or 20 mg
Drug: Nebivolol
Metoprolol ER 50 mg, 100 mg or 200 mg
Drug: Metoprolol ER
Metoprolol ER once daily, oral administration
Nebivolol once daily, oral administration
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).
Time frame: Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12)
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)
Patient recruitment occurred over a four month period from October 2007 to January 2008 at 39 US sites.
| Milestone | Nebivolol | Metoprolol Extended-Release (ER) |
|---|---|---|
| Started | 25 | 26 |
| Completed | 0 | 0 |
| Not completed | 25 | 26 |
| Withdrew: Study was administratively terminated | 25 | 24 |
| Withdrew: Did not meet entry criteria | 0 | 2 |
The PSQ contained 44 possible symptoms rated from 0 (no discomfort) to 5 (extreme discomfort).
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over Adverse Event data was collected over a four month period from October 2007 to January 2008.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nebivolol | 0/25 (0%) | 0/25 (0%) | 5/25 (20%) |
| Metoprolol Extended-Release (ER) | 0/26 (0%) | 0/26 (0%) | 3/24 (12.5%) |
| Event | Nebivolol | Metoprolol Extended-Release (ER) |
|---|---|---|
| HeadacheNervous system disorders | 1/25 | 2/24 |
| PainGeneral disorders | 2/25 | 0/24 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/25 | 0/24 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 2/25 | 0/24 |
| NasopharyngitisInfections and infestations | 2/25 | 1/24 |
| Age, Categorical(Participants) | Nebivolol | Metoprolol Extended-Release (ER) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 22 | 19 | 41 |
| >=65 years | 3 | 5 | 8 |
| Age, Continuous(years) | Nebivolol | Metoprolol Extended-Release (ER) | Total |
|---|---|---|---|
| Mean | 55.0 ± 8.67 | 57.0 ± 9.32 | 56.0 ± 8.95 |
| Sex: Female, Male(Participants) | Nebivolol | Metoprolol Extended-Release (ER) | Total |
|---|---|---|---|
| Female | 13 | 11 | 24 |
| Male | 12 | 13 | 25 |
| Region of Enrollment(Participants) | Nebivolol | Metoprolol Extended-Release (ER) | Total |
|---|---|---|---|
| United States | 25 | 24 | 49 |
This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Forest Laboratories