Trial · NCT00922480
Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Hypertension Patients
NCT00922480, Phase 3, Completed, Boryung Pharmaceutical Co., Ltd; results first posted 2018-02-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Hypertension Patients. Trials, record NCT00922480. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00922480
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Hypertension Patients
- NCT number
- NCT00922480
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 506 participants, actual
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Conditions
- Hypertension
- Interventions
- Fimasartan, Losartan (Control)
- First posted
- 2009-06-17
- Last updated
- 2018-04-10
- Results first posted
- 2018-02-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Diastolic Blood Pressure Change | baseline and 12 weeks | Value of DBP at 12 Weeks minus value of DBP at Baseline while in a sitting position |
| Secondary | Diastolic Blood Pressure Change | baseline and 4 weeks, 8 weeks | * Value of DBP at 4 Weeks minus value of DBP at Baseline while in a sitting position * Value of DBP at 8 Weeks minus value of DBP at Baseline while in a sitting position |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Diastolic Blood Pressure Change | baseline and 12 weeks | As ITT group, these are subjects who have been randomly assigned and have at least one primary end point. | mmHg | MEAN |
| SECONDARY | Diastolic Blood Pressure Change | baseline and 4 weeks, 8 weeks | As ITT group, these are subjects who have been randomly assigned and have at least one primary end point. | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Diastolic Blood Pressure Change | Control: Losartan / Week 12 -ITT | -8.56 | Standard Deviation 7.72 | mmHg | |
| Diastolic Blood Pressure Change | Test: Fimasartan / Week 12 -ITT | -11.26 | Standard Deviation 7.53 | mmHg | |
| Diastolic Blood Pressure Change | Control: Losartan / Week 4,8 -ITT | Week 4 | -5.73 | Standard Deviation 6.56 | mmHg |
| Diastolic Blood Pressure Change | Test: Fimasartan / Week 4,8 -ITT | Week 4 | -8.22 | Standard Deviation 7.35 | mmHg |
| Diastolic Blood Pressure Change | Control: Losartan / Week 4,8 -ITT | Week 8 | -8.01 | Standard Deviation 7.16 | mmHg |
| Diastolic Blood Pressure Change | Test: Fimasartan / Week 4,8 -ITT | Week 8 | -11.01 | Standard Deviation 7.63 | mmHg |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Study | STARTED | Control: Losartan | 250 | |
| Main Study | STARTED | Test: Fimasartan | 255 | |
| Main Study | COMPLETED | Control: Losartan | 213 | |
| Main Study | COMPLETED | Test: Fimasartan | 226 | |
| Main Study | NOT COMPLETED | Control: Losartan | 37 | |
| Main Study | NOT COMPLETED | Test: Fimasartan | 29 | |
| Extension Study | STARTED | Control: Losartan | 73 | |
| Extension Study | STARTED | Test: Fimasartan | 85 | |
| Extension Study | COMPLETED | Control: Losartan | 68 | |
| Extension Study | COMPLETED | Test: Fimasartan | 82 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events226
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 | Control: Losartan | 17 | 250 | 18 |
| other | Headache | Nervous system disorders | Test: Fimasartan | 16 | 255 | 17 |
| other | Dizziness | Nervous system disorders | Control: Losartan | 9 | 250 | 10 |
| other | Dizziness | Nervous system disorders | Test: Fimasartan | 11 | 255 | 11 |
| other | Hypoaesthesia | Nervous system disorders | Control: Losartan | 2 | 250 | 2 |
| other | Hypoaesthesia | Nervous system disorders | Test: Fimasartan | 0 | 255 | 0 |
| other | Migraine | Nervous system disorders | Control: Losartan | 0 | 250 | 0 |
| other | Migraine | Nervous system disorders | Test: Fimasartan | 2 | 255 | 2 |
| other | Dysaesthesia | Nervous system disorders | Control: Losartan | 1 | 250 | 1 |
| other | Dysaesthesia | Nervous system disorders | Test: Fimasartan | 0 | 255 | 0 |
1 to 10 of 226Source ClinicalTrials.gov
See all 226 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control: Losartan | ||
| Total, all-cause mortality | Test: Fimasartan | ||
| Total, other adverse events | Control: Losartan | 76 | 250 |
| Total, other adverse events | Test: Fimasartan | 82 | 255 |
| Total, serious adverse events | Control: Losartan | 5 | 250 |
| Total, serious adverse events | Test: Fimasartan | 3 | 255 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| Control: Losartan vs Test: Fimasartan: 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/NCT00922480
GET https://conductscience.org/api/trials/v1/NCT00922480/events?page=2