Trial · NCT01307046
MK-0954A in Japanese Patients With Essential Hypertension Not Adequately Controlled With Losartan (MK-0954A-352)
NCT01307046, Phase 3, Completed, Organon and Co; results first posted 2013-03-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. MK-0954A in Japanese Patients With Essential Hypertension Not Adequately Controlled With Losartan (MK-0954A-352). Trials, record NCT01307046. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01307046
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MK-0954A in Japanese Patients With Essential Hypertension Not Adequately Controlled With Losartan (MK-0954A-352)
- NCT number
- NCT01307046
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 336 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Hypertension
- Interventions
- MK-0954A, Losartan, Placebo to MK-0954A, Placebo to losartan 100 mg, Placebo to losartan 50 mg
- First posted
- 2011-03-02
- Last updated
- 2024-05-17
- Results first posted
- 2013-03-22
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 Trough Sitting Diastolic Blood Pressure (SiDBP) | Baseline and Week 8 | Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days). |
| Primary | Percentage of Participants Who Experienced at Least One Adverse Event (AE) | 8 weeks | |
| Secondary | Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) | Baseline and Week 8 | Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days). |
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 Trough Sitting Diastolic Blood Pressure (SiDBP) | Baseline and Week 8 | Full Analysis Set (FAS) population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent~to at least one dose of study treatment, and had baseline data for those analyses that required baseline data | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) | Baseline and Week 8 | Full Analysis Set (FAS) Population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent~to at least one dose of study treatment, and had baseline data for those analyses that required baseline data | mmHg | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants Who Experienced at Least One Adverse Event (AE) | 8 weeks | All-Patients-as-Treated (APaT) Population: defined as all randomized participants who received at least one dose of study treatment. | percentage of participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) | MK-0954A | -8.7 | 95% Confidence Interval 0.6 | mmHg | |
| Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) | Losartan | -3.6 | 95% Confidence Interval 0.6 | mmHg | |
| Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) | MK-0954A | -14.5 | 95% Confidence Interval -16.5 to -12.6 | mmHg | |
| Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) | Losartan | -5.4 | 95% Confidence Interval -7.3 to -3.4 | mmHg | |
| Percentage of Participants Who Experienced at Least One Adverse Event (AE) | MK-0954A | 31.3 | percentage of participants | ||
| Percentage of Participants Who Experienced at Least One Adverse Event (AE) | Losartan | 26.5 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MK-0954A | 166 | |
| Overall Study | STARTED | Losartan | 170 | |
| Overall Study | COMPLETED | MK-0954A | 154 | |
| Overall Study | COMPLETED | Losartan | 159 | |
| Overall Study | NOT COMPLETED | MK-0954A | 12 | |
| Overall Study | NOT COMPLETED | Losartan | 11 |
Source ClinicalTrials.gov
Adverse events2
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 | MK-0954A | 9 | 166 | 11 |
| other | Nasopharyngitis | Infections and infestations | Losartan | 9 | 170 | 10 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MK-0954A | ||
| Total, all-cause mortality | Losartan | ||
| Total, other adverse events | MK-0954A | 9 | 166 |
| Total, other adverse events | Losartan | 9 | 170 |
| Total, serious adverse events | MK-0954A | 0 | 166 |
| Total, serious adverse events | Losartan | 0 | 170 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24990091 | RESULT |
Source PubMed
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 |
|---|
| MK-0954A vs Losartan: 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/NCT01307046
GET https://conductscience.org/api/trials/v1/NCT01307046/registered