Trial · NCT00888355
MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension
NCT00888355, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2009-06-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension. Trials, record NCT00888355. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00888355
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension
- NCT number
- NCT00888355
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 428 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hypertension
- Interventions
- losartan potassium, Comparator: placebo
- First posted
- 2009-04-27
- Last updated
- 2009-07-09
- Results first posted
- 2009-06-24
- Limitations and caveats
- Note that deaths are not entered under drop reasons in the participant flow panel because the patients who died are already counted as dropped due to adverse event.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose) | Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiDBP at Week 12 |
| Secondary | Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12 | At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose) | Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiSBP at Week 12 |
| Secondary | Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | At baseline and at 12 weeks (6 hours after last morning dose) | Mean change from baseline in peak (6 hours after the last morning dose) SiDBP at Week 12 |
| Secondary | Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | 24 hours after last morning dose and 12 hours after last PM dose at 12 weeks | Patients with trough SiDBP \<90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg or increased were in Category III. |
| Other | Number of Patients With Clinical Adverse Experiences (CAEs) | 12 weeks | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product |
| Other | Number of Patients With Serious CAEs | 12 weeks | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose |
| Other | Number of Patients With Drug-related CAEs | 12 weeks | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs during the 12-week treatment period |
| Other | Number of Patients Discontinued Due to CAEs | 12 weeks | Patients discontinued due to CAEs during the 12-week treatment period |
| Other | Number of Patients Who Died | 12 weeks | Patients who died during the 12-week treatment period |
| Other | Number of Patients With Laboratory Adverse Experiences (LAEs) | 12 weeks | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose) | The primary analysis employed an all patients treated approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available. | mm Hg | MEAN |
| SECONDARY | Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12 | At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose) | An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available. | mm Hg | MEAN |
| SECONDARY | Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | At baseline and at 12 weeks (6 hours after last morning dose) | An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available. | mm Hg | MEAN |
| SECONDARY | Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | 24 hours after last morning dose and 12 hours after last PM dose at 12 weeks | An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Patients With Clinical Adverse Experiences (CAEs) | 12 weeks | All patients who took study medication were included in the analysis. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Patients With Serious CAEs | 12 weeks | All patients who took study medication were included in the analysis. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Patients With Drug-related CAEs | 12 weeks | All patients who took study medication were included in the analysis. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Patients Discontinued Due to CAEs | 12 weeks | All patients who took study medication were included in the analysis. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Patients Who Died | 12 weeks | All patients who took study medication were included in the analysis. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Patients With Laboratory Adverse Experiences (LAEs) | 12 weeks | All patients who took study medication and had any laboratory tests performed were included in the analysis. | Participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Placebo | -2.0 | Standard Deviation 8.4 | mm Hg | |
| Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Losartan 25 mg q.d. | -5.8 | Standard Deviation 6.7 | mm Hg | |
| Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Losartan 50 mg q.d. | -6.3 | Standard Deviation 7.4 | mm Hg | |
| Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Losartan 25 mg (b.i.d.) | -8.0 | Standard Deviation 7.9 | mm Hg | |
| Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12 | Placebo | -0.2 | Standard Deviation 15.1 | mm Hg | |
| Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12 | Losartan 25 mg q.d. | -7.2 | Standard Deviation 13.9 | mm Hg | |
| Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12 | Losartan 50 mg q.d. | -7.6 | Standard Deviation 12.6 | mm Hg | |
| Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12 | Losartan 25 mg (b.i.d.) | -8.8 | Standard Deviation 13.0 | mm Hg | |
| Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Placebo | -3.0 | Standard Deviation 9.7 | mm Hg | |
| Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Losartan 25 mg q.d. | -7.7 | Standard Deviation 8.5 | mm Hg |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 108 | |
| Overall Study | STARTED | Losartan 25 mg q.d. | 108 | |
| Overall Study | STARTED | Losartan 50 mg q.d. | 106 | |
| Overall Study | STARTED | Losartan 25 mg (b.i.d.) | 106 | |
| Overall Study | COMPLETED | Placebo | 86 | |
| Overall Study | COMPLETED | Losartan 25 mg q.d. | 99 | |
| Overall Study | COMPLETED | Losartan 50 mg q.d. | 94 | |
| Overall Study | COMPLETED | Losartan 25 mg (b.i.d.) | 96 | |
| Overall Study | NOT COMPLETED | Placebo | 22 | |
| Overall Study | NOT COMPLETED | Losartan 25 mg q.d. | 9 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT00888355
GET https://conductscience.org/api/trials/v1/NCT00888355/results?page=2