Trial · NCT00547300
Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-release (ER) for Hypertension
NCT00547300, Phase 3, Terminated, Forest Laboratories; results first posted 2019-05-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-release (ER) for Hypertension. Trials, record NCT00547300. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00547300
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-release (ER) for Hypertension
- NCT number
- NCT00547300
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 49 participants, actual
- Lead sponsor
- Forest Laboratories
- Conditions
- Hypertension
- Interventions
- Metoprolol ER, Nebivolol
- First posted
- 2007-10-22
- Last updated
- 2019-05-21
- Results first posted
- 2019-05-21
- Limitations and caveats
- Study was terminated early due to administrative reasons. Formal analyses of primary and secondary endpoints were not conducted in this study.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score | 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). |
| Secondary | Peripheral Blood Pressure (BP) | Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14) | |
| Secondary | Pulse Rate | Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score | Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12) | Formal analysis of the primary endpoint was not conducted in this abbreviated study as the study was terminated before visit 10 was reached. | ||
| SECONDARY | Peripheral Blood Pressure (BP) | Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14) | Formal analysis of the secondary endpoint was not conducted in this abbreviated study as the study was terminated before all visits were completed. No patients completed the study. | ||
| SECONDARY | Pulse Rate | Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14) | Formal analysis of the secondary endpoint was not conducted in this abbreviated study as the study was terminated before all visits were completed. No patients completed the study. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nebivolol | 25 | |
| Overall Study | STARTED | Metoprolol Extended-Release (ER) | 26 | |
| Overall Study | COMPLETED | Nebivolol | 0 | |
| Overall Study | COMPLETED | Metoprolol Extended-Release (ER) | 0 | |
| Overall Study | NOT COMPLETED | Nebivolol | 25 | |
| Overall Study | NOT COMPLETED | Metoprolol Extended-Release (ER) | 26 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pain | General disorders | Nebivolol | 2 | 25 | |
| other | Pain | General disorders | Metoprolol Extended-Release (ER) | 0 | 24 | |
| other | Headache | Nervous system disorders | Nebivolol | 1 | 25 | |
| other | Headache | Nervous system disorders | Metoprolol Extended-Release (ER) | 2 | 24 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Nebivolol | 2 | 25 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Metoprolol Extended-Release (ER) | 0 | 24 | |
| other | Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Nebivolol | 2 | 25 | |
| other | Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Metoprolol Extended-Release (ER) | 0 | 24 | |
| other | Nasopharyngitis | Infections and infestations | Nebivolol | 2 | 25 | |
| other | Nasopharyngitis | Infections and infestations | Metoprolol Extended-Release (ER) | 1 | 24 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nebivolol | 0 | 25 |
| Total, all-cause mortality | Metoprolol Extended-Release (ER) | 0 | 26 |
| Total, other adverse events | Nebivolol | 5 | 25 |
| Total, other adverse events | Metoprolol Extended-Release (ER) | 3 | 24 |
| Total, serious adverse events | Nebivolol | 0 | 25 |
| Total, serious adverse events | Metoprolol Extended-Release (ER) | 0 | 26 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nebivolol vs Metoprolol Extended-Release (ER): deaths from any cause | Trial comparisons |
| Nebivolol vs Metoprolol Extended-Release (ER): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00547300
GET https://conductscience.org/api/trials/v1/NCT00547300/registered