Trial · NCT01631227
Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension
NCT01631227, Phase 3, Completed, Abbott; results first posted 2014-05-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension. Trials, record NCT01631227. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01631227
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension
- NCT number
- NCT01631227
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 665 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Essential Hypertension
- Interventions
- Eprosartan, Eprosartan Mesylate, Placebo Eprosartan mesylate, Placebo Eprosartan
- First posted
- 2012-06-29
- Last updated
- 2014-07-25
- Other registries' IDs
- eudract:2010-019432-12
- Results first posted
- 2014-05-26
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assess the Therapeutic Equivalence of Eprosartan (a New Formulation Containing Only the Active Moiety Eprosartan) With Eprosartan Mesylate (Currently Marketed Formulation) on Change of Sitting Diastolic Blood Pressure (DBP) From Baseline | 8 weeks | Change from baseline of diastolic blood pressure (DBP), sitting |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Assess the Therapeutic Equivalence of Eprosartan (a New Formulation Containing Only the Active Moiety Eprosartan) With Eprosartan Mesylate (Currently Marketed Formulation) on Change of Sitting Diastolic Blood Pressure (DBP) From Baseline | 8 weeks | Full analysis subject sample | mmHg | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Assess the Therapeutic Equivalence of Eprosartan (a New Formulation Containing Only the Active Moiety Eprosartan) With Eprosartan Mesylate (Currently Marketed Formulation) on Change of Sitting Diastolic Blood Pressure (DBP) From Baseline | Eprosartan | -7.4 | Standard Deviation 7.7 | mmHg | |
Assess the Therapeutic Equivalence of Eprosartan (a New Formulation Containing Only the Active Moiety Eprosartan) With Eprosartan Mesylate (Currently Marketed Formulation) on Change of Sitting Diastolic Blood Pressure (DBP) From Baseline | Eprosartan Mesylate | -7.2 | Standard Deviation 7.5 | mmHg |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Eprosartan | 333 | |
| Overall Study | STARTED | Eprosartan Mesylate | 332 | |
| Overall Study | Safety Subject Sample | Eprosartan | 332 | |
| Overall Study | Safety Subject Sample | Eprosartan Mesylate | 332 | |
| Overall Study | Full Analysis Set Population | Eprosartan | 330 | |
| Overall Study | Full Analysis Set Population | Eprosartan Mesylate | 331 | |
| Overall Study | COMPLETED | Eprosartan | 303 | |
| Overall Study | COMPLETED | Eprosartan Mesylate | 310 | |
| Overall Study | NOT COMPLETED | Eprosartan | 30 | |
| Overall Study | NOT COMPLETED | Eprosartan Mesylate | 22 |
Source ClinicalTrials.gov
Adverse events26
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 | NASOPHARYNGITIS | Infections and infestations | Eprosartan | 15 | 332 | 15 |
| other | NASOPHARYNGITIS | Infections and infestations | Eprosartan Mesylate | 18 | 332 | 18 |
| serious | GASTRITIS HAEMORRHAGIC | Gastrointestinal disorders | Eprosartan | 0 | 332 | 0 |
| serious | GASTRITIS HAEMORRHAGIC | Gastrointestinal disorders | Eprosartan Mesylate | 1 | 332 | 1 |
| serious | GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | Eprosartan | 0 | 332 | 0 |
| serious | GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | Eprosartan Mesylate | 1 | 332 | 1 |
| serious | TIBIA FRACTURE | Injury, poisoning and procedural complications | Eprosartan | 1 | 332 | 1 |
| serious | TIBIA FRACTURE | Injury, poisoning and procedural complications | Eprosartan Mesylate | 0 | 332 | 0 |
| serious | FOREARM FRACTURE | Injury, poisoning and procedural complications | Eprosartan | 0 | 332 | 0 |
| serious | FOREARM FRACTURE | Injury, poisoning and procedural complications | Eprosartan Mesylate | 1 | 332 | 1 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Eprosartan | ||
| Total, all-cause mortality | Eprosartan Mesylate | ||
| Total, other adverse events | Eprosartan | 15 | 332 |
| Total, other adverse events | Eprosartan Mesylate | 18 | 332 |
| Total, serious adverse events | Eprosartan | 3 | 332 |
| Total, serious adverse events | Eprosartan Mesylate | 7 | 332 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Eprosartan vs Eprosartan Mesylate: serious adverse events |
Source 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/NCT01631227
GET https://conductscience.org/api/trials/v1/NCT01631227/events?page=2