Trial · NCT00749775
Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
NCT00749775, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2014-01-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan). Trials, record NCT00749775. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00749775
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
- NCT number
- NCT00749775
- Status
- Completed
- Enrollment
- 3,338 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Hypertension
- Interventions
- Selara
- First posted
- 2008-09-09
- Last updated
- 2020-12-22
- Results first posted
- 2014-01-08
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Related Adverse Events. | 12 weeks | Adverse events mean all unfavorable events that occur in participants after administration of Selara, irrespective of causal relationship to Selara (including clinically problematic abnormal changes in laboratory test values). Treatment Related Adverse Events were evaluated in company with the causal relationship to Selara. |
| Primary | Number of Participants With Serious Treatment Related Adverse Events. | 12 weeks | Serious treatment related adverse events mean those that may lead to death, life-threatening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anomaly/congenital deficiency, or other medically significant events or disorder. |
| Secondary | Change in Systolic Blood Pressure Over Time. | 12 weeks | The primary analysis item was the mean systolic blood pressure at 4, 8, and 12 weeks of the observation period or at last evaluation date if Selara was terminated prematurely. |
| Secondary | Change in Diastolic Blood Pressure Over Time. | 12 weeks | The primary analysis item was the mean diastolic blood pressure at 4, 8, and 12 weeks of the observation period or at last evaluation date if Selara was terminated prematurely. |
| Secondary | Number of Participants That Responded to Selara Treatment. | 12 weeks | Number of participants among the efficacy analysis population that responded to Selara treatment. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Related Adverse Events. | 12 weeks | No statistical analysis provided for the frequency of Treatment Related adverse events. | participants | NUMBER |
| PRIMARY | Number of Participants With Serious Treatment Related Adverse Events. | 12 weeks | No statistical analysis provided for the frequency of serious treatment related adverse events. | participants | NUMBER |
| SECONDARY | Change in Systolic Blood Pressure Over Time. | 12 weeks | The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). | mmHg | MEAN |
| SECONDARY | Change in Diastolic Blood Pressure Over Time. | 12 weeks | The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). | mmHg | MEAN |
| SECONDARY | Number of Participants That Responded to Selara Treatment. | 12 weeks | The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). | participants | NUMBER |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Related Adverse Events. | Selara | 75 | participants | ||
| Number of Participants With Serious Treatment Related Adverse Events. | Selara | 16 | participants | ||
| Change in Systolic Blood Pressure Over Time. | At Baseline | 151.8 | Standard Deviation 19.6 | mmHg | |
| Change in Systolic Blood Pressure Over Time. | At 4 Weeks | 140.7 | Standard Deviation 17.7 | mmHg | |
| Change in Systolic Blood Pressure Over Time. | At 8 Weeks | 137.5 | Standard Deviation 16.2 | mmHg | |
| Change in Systolic Blood Pressure Over Time. | At 12 Weeks | 134.7 | Standard Deviation 15.6 | mmHg | |
| Change in Systolic Blood Pressure Over Time. | At Last Evaluation Date | 134.0 | Standard Deviation 15.9 | mmHg | |
| Change in Diastolic Blood Pressure Over Time. | At Baseline | 85.1 | Standard Deviation 13.9 | mmHg | |
| Change in Diastolic Blood Pressure Over Time. | At 4 Weeks | 79.5 | Standard Deviation 12.9 | mmHg | |
| Change in Diastolic Blood Pressure Over Time. | At 8 Weeks | 78.0 | Standard Deviation 12.5 | mmHg |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Selara | 3,317 | |
| Overall Study | COMPLETED | Selara | 3,210 | |
| Overall Study | NOT COMPLETED | Selara | 107 |
Source ClinicalTrials.gov
Adverse events42
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 | Herpes zoster | Infections and infestations | Selara | 1 | 3,210 | 1 |
| other | Lymphadenitis | Blood and lymphatic system disorders | Selara | 1 | 3,210 | 1 |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Selara | 11 | 3,210 | 11 |
| other | Hyperuricaemia | Metabolism and nutrition disorders | Selara | 1 | 3,210 | 1 |
| other | Dehydration | Metabolism and nutrition disorders | Selara | 1 | 3,210 | 1 |
| other | Hyponatraemia | Metabolism and nutrition disorders | Selara | 2 | 3,210 | 2 |
| other | Hypoaesthesia | Nervous system disorders | Selara | 1 | 3,210 | 1 |
| other | Headache | Nervous system disorders | Selara | 1 | 3,210 | 1 |
| other | Dizziness | Nervous system disorders | Selara | 7 | 3,210 | 7 |
| other | Convulsion | Nervous system disorders | Selara | 1 | 3,210 | 1 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Selara | ||
| Total, other adverse events | Selara | 59 | 3,210 |
| Total, serious adverse events | Selara | 16 | 3,210 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00749775
GET https://conductscience.org/api/trials/v1/NCT00749775/events?page=2