Trial · NCT00142584
Evaluation of the Long-term Safety and Tolerability of Metoprolol Versus Nebivolol in Patients With Hypertension
NCT00142584, Phase 3, Completed, Mylan Bertek Pharmaceuticals; results first posted 2022-03-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of the Long-term Safety and Tolerability of Metoprolol Versus Nebivolol in Patients With Hypertension. Trials, record NCT00142584. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00142584
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Long-term Safety and Tolerability of Metoprolol Versus Nebivolol in Patients With Hypertension
- NCT number
- NCT00142584
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 336 participants, actual
- Lead sponsor
- Mylan Bertek Pharmaceuticals
- Conditions
- Hypertension
- Interventions
- Nebivolol (NEB), Metoprolol (MET)
- First posted
- 2005-09-02
- Last updated
- 2022-03-15
- Results first posted
- 2022-03-15
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Average Sitting Diastolic Blood Pressure (DBP) Taken at Trough at the End of Treatment Compared to Baseline | Through study duration (approximately 18 months) | The primary efficacy parameter was the change in the average trough sitting DBP at the end of treatment (Visit 10 or Early Termination) compared with baseline (baseline was defined as the baseline visit in Study NEB 310 \[NCT00145210\]). |
| Secondary | Change From Baseline in Mean Trough Sitting Diastolic Blood Pressure (DBP) at Each Study Visit (Visits 1 Through 9) Compared to Baseline | Through study completion (approximately 18 months) | Data for the analysis of the change from baseline in mean trough sitting DBP at each study visit (Visits 1 through 9) compared with baseline (baseline was defined as the baseline visit in Study NEB 310 \[NCT00145210\]) by treatment group are provided below. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Through study completion (approximately 18 months) | Summary of Participants that experienced one or more TEAEs by Treatment Group-Safety Population |
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 in Average Sitting Diastolic Blood Pressure (DBP) Taken at Trough at the End of Treatment Compared to Baseline | Through study duration (approximately 18 months) | mm Hg | MEAN | |
| SECONDARY | Change From Baseline in Mean Trough Sitting Diastolic Blood Pressure (DBP) at Each Study Visit (Visits 1 Through 9) Compared to Baseline | Through study completion (approximately 18 months) | The overall number of participants analyzed equals the number of randomized patients at study start; the numbers analyzed at each visit equal the number of patients at each treatment visit. | mm Hg | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Through study completion (approximately 18 months) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Average Sitting Diastolic Blood Pressure (DBP) Taken at Trough at the End of Treatment Compared to Baseline | 1-NEB | -14.0 | Standard Deviation 9.80 | mm Hg | |
| Change in Average Sitting Diastolic Blood Pressure (DBP) Taken at Trough at the End of Treatment Compared to Baseline | 2-MET | -10.9 | Standard Deviation 8.73 | mm Hg | |
| Change From Baseline in Mean Trough Sitting Diastolic Blood Pressure (DBP) at Each Study Visit (Visits 1 Through 9) Compared to Baseline | 1-NEB | Visit 1 | -8.3 | Standard Deviation 8.24 | mm Hg |
| Change From Baseline in Mean Trough Sitting Diastolic Blood Pressure (DBP) at Each Study Visit (Visits 1 Through 9) Compared to Baseline | 2-MET | Visit 1 | -8.4 | Standard Deviation 9.15 | mm Hg |
| Change From Baseline in Mean Trough Sitting Diastolic Blood Pressure (DBP) at Each Study Visit (Visits 1 Through 9) Compared to Baseline | 1-NEB | Visit 2 | -8.4 | Standard Deviation 8.39 | mm Hg |
| Change From Baseline in Mean Trough Sitting Diastolic Blood Pressure (DBP) at Each Study Visit (Visits 1 Through 9) Compared to Baseline | 2-MET | Visit 2 | -8.4 | Standard Deviation 7.89 | mm Hg |
| Change From Baseline in Mean Trough Sitting Diastolic Blood Pressure (DBP) at Each Study Visit (Visits 1 Through 9) Compared to Baseline | 1-NEB | Visit 3 | -10.6 | Standard Deviation 8.51 | mm Hg |
| Change From Baseline in Mean Trough Sitting Diastolic Blood Pressure (DBP) at Each Study Visit (Visits 1 Through 9) Compared to Baseline | 2-MET | Visit 3 | -9.8 | Standard Deviation 8.07 | mm Hg |
| Change From Baseline in Mean Trough Sitting Diastolic Blood Pressure (DBP) at Each Study Visit (Visits 1 Through 9) Compared to Baseline | 1-NEB | Visit 4 | -12.1 | Standard Deviation 8.55 | mm Hg |
| Change From Baseline in Mean Trough Sitting Diastolic Blood Pressure (DBP) at Each Study Visit (Visits 1 Through 9) Compared to Baseline | 2-MET | Visit 4 | -10.7 | Standard Deviation 8.20 | mm Hg |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1-NEB | 252 | |
| Overall Study | STARTED | 2-MET | 84 | |
| Overall Study | COMPLETED | 1-NEB | 108 | |
| Overall Study | COMPLETED | 2-MET | 28 | |
| Overall Study | NOT COMPLETED | 1-NEB | 144 | |
| Overall Study | NOT COMPLETED | 2-MET | 56 |
Source ClinicalTrials.gov
Adverse events52
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 | HEADACHE | Nervous system disorders | 1-NEB | 17 | 252 | |
| other | HEADACHE | Nervous system disorders | 2-MET | 3 | 84 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | 1-NEB | 14 | 252 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | 2-MET | 4 | 84 | |
| other | Nasopharyngitis | Infections and infestations | 1-NEB | 12 | 252 | |
| other | Nasopharyngitis | Infections and infestations | 2-MET | 1 | 84 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | 1-NEB | 10 | 252 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | 2-MET | 4 | 84 | |
| other | Upper respiratory tract infection | Infections and infestations | 1-NEB | 8 | 252 | |
| other | Upper respiratory tract infection | Infections and infestations | 2-MET | 4 | 84 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1-NEB | 3 | 252 |
| Total, all-cause mortality | 2-MET | 0 | 84 |
| Total, other adverse events | 1-NEB | 74 | 252 |
| Total, other adverse events | 2-MET | 28 | 84 |
| Total, serious adverse events | 1-NEB | 11 | 252 |
| Total, serious adverse events | 2-MET | 2 | 84 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 1-NEB vs 2-MET: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Trial comparisons |
| 1-NEB vs 2-MET: deaths from any cause | Trial comparisons |
| 1-NEB vs 2-MET: 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/NCT00142584
GET https://conductscience.org/api/trials/v1/NCT00142584/results?page=2