Trial · NCT01302691
MK-0954E Study in Participants With Hypertension (MK-0954E-357)
NCT01302691, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2017-01-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. MK-0954E Study in Participants With Hypertension (MK-0954E-357). Trials, record NCT01302691. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01302691
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MK-0954E Study in Participants With Hypertension (MK-0954E-357)
- NCT number
- NCT01302691
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 327 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hypertension
- Interventions
- losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E), Losartan potassium, Amlodipine besylate, Placebo to MK-0954E, Placebo to losartan potassium, Placebo to amlodipine besylate
- First posted
- 2011-02-24
- Last updated
- 2019-03-15
- Results first posted
- 2017-01-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mean 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 at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm. |
| Primary | Percentage of Participants Who Experience ≥1 Adverse Event (AE) | up to 14 days after last dose of study drug (up to 10 weeks) | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced at least 1 AE during the 10-week treatment and follow-up period were summarized by study drug received. |
| Primary | Percentage of Participants Who Experience ≥1 Drug-related AE | up to 14 days after last dose of study drug (up to 10 weeks) | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 10-week treatment and follow-up period were summarized by study drug received. |
| Primary | Percentage of Participants Who Experience ≥1 Serious Adverse Event (SAE) | up to 14 days after last dose of study drug (up to 10 weeks) | An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. The percentage of participants who experienced at least 1 SAE during the 10-week treatment and follow-up period were summarized by study drug received. |
| Primary | Percentage of Participants Who Experience ≥1 Drug-related SAE | up to 14 days after last dose of study drug (up to 10 weeks) | An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Percentage of participants that experienced at least 1 SAE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 10-week treatment and follow-up period were summarized by study drug received |
| Primary | Percentage of Participants Who Had Study Drug Stopped Due to an AE | up to 8 weeks | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug stopped during the 8-week treatment period due to an AE regardless of whether or not they completed the study was summarized by treatment arm |
| Secondary | Change in Mean 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 at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Mean Trough Sitting Diastolic Blood Pressure (SiDBP) | Baseline and Week 8 | All participants that received at least one dose of study treatment, had at least 1 post-randomization observation for the analysis endpoint, and had baseline data | mmHg | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants Who Experience ≥1 Adverse Event (AE) | up to 14 days after last dose of study drug (up to 10 weeks) | All randomized participants who received at least 1 dose of study drug. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experience ≥1 Drug-related AE | up to 14 days after last dose of study drug (up to 10 weeks) | All randomized participants who received at least 1 dose of study drug. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experience ≥1 Serious Adverse Event (SAE) | up to 14 days after last dose of study drug (up to 10 weeks) | All randomized participants who received at least 1 dose of study drug. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experience ≥1 Drug-related SAE | up to 14 days after last dose of study drug (up to 10 weeks) | All randomized participants who received at least 1 dose of study drug. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants Who Had Study Drug Stopped Due to an AE | up to 8 weeks | All randomized participants who received at least 1 dose of study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Change in Mean Trough Sitting Systolic Blood Pressure (SiSBP) | Baseline and Week 8 | All participants that received at least one dose of study treatment, had at least 1 post-randomization observation for the analysis endpoint, and had baseline data | mmHg | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Mean Trough Sitting Diastolic Blood Pressure (SiDBP) | L50/H12.5/A5 | -9.1 | 95% Confidence Interval -10.2 to -7.9 | mmHg | |
| Change in Mean Trough Sitting Diastolic Blood Pressure (SiDBP) | L50 + A5 | -8.0 | 95% Confidence Interval -9.1 to -6.8 | mmHg | |
| Percentage of Participants Who Experience ≥1 Adverse Event (AE) | L50/H12.5/A5 | 30.5 | Percentage of Participants | ||
| Percentage of Participants Who Experience ≥1 Adverse Event (AE) | L50 + A5 | 28.8 | Percentage of Participants | ||
| Percentage of Participants Who Experience ≥1 Drug-related AE | L50/H12.5/A5 | 11.6 | Percentage of Participants | ||
| Percentage of Participants Who Experience ≥1 Drug-related AE | L50 + A5 | 3.7 | Percentage of Participants | ||
| Percentage of Participants Who Experience ≥1 Serious Adverse Event (SAE) | L50/H12.5/A5 | 0.6 | Percentage of Participants | ||
| Percentage of Participants Who Experience ≥1 Serious Adverse Event (SAE) | L50 + A5 | 0.6 | Percentage of Participants | ||
| Percentage of Participants Who Experience ≥1 Drug-related SAE | L50/H12.5/A5 | 0.0 | Percentage of Participants | ||
| Percentage of Participants Who Experience ≥1 Drug-related SAE | L50 + A5 | 0.0 | Percentage of Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | L50/H12.5/A5 | 164 | |
| Overall Study | STARTED | L50 + A5 | 163 | |
| Overall Study | COMPLETED | L50/H12.5/A5 | 154 | |
| Overall Study | COMPLETED | L50 + A5 | 157 | |
| Overall Study | NOT COMPLETED | L50/H12.5/A5 | 10 | |
| Overall Study | NOT COMPLETED | L50 + A5 | 6 |
Source ClinicalTrials.gov
Adverse events10
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 | L50/H12.5/A5 | 11 | 164 | 11 |
| other | Nasopharyngitis | Infections and infestations | L50 + A5 | 15 | 163 | 15 |
| serious | Sudden cardiac death | General disorders | L50/H12.5/A5 | 0 | 164 | 0 |
| serious | Sudden cardiac death | General disorders | L50 + A5 | 1 | 163 | 1 |
| serious | Clavicle fracture | Injury, poisoning and procedural complications | L50/H12.5/A5 | 1 | 164 | 1 |
| serious | Clavicle fracture | Injury, poisoning and procedural complications | L50 + A5 | 0 | 163 | 0 |
| serious | Rib fracture | Injury, poisoning and procedural complications | L50/H12.5/A5 | 1 | 164 | 1 |
| serious | Rib fracture | Injury, poisoning and procedural complications | L50 + A5 | 0 | 163 | 0 |
| serious | Pneumothorax | Respiratory, thoracic and mediastinal disorders | L50/H12.5/A5 | 1 | 164 | 1 |
| serious | Pneumothorax | Respiratory, thoracic and mediastinal disorders | L50 + A5 | 0 | 163 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | L50/H12.5/A5 | ||
| Total, all-cause mortality | L50 + A5 | ||
| Total, other adverse events | L50/H12.5/A5 | 11 | 164 |
| Total, other adverse events | L50 + A5 | 15 | 163 |
| Total, serious adverse events | L50/H12.5/A5 | 1 | 164 |
| Total, serious adverse events | L50 + A5 | 1 | 163 |
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 |
|---|
| L50/H12.5/A5 vs L50 + A5: 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/NCT01302691
GET https://conductscience.org/api/trials/v1/NCT01302691/registered