Trial · NCT00949884
Olmesartan Comparison to Losartan in Hypertensive Subjects
NCT00949884, Phase 4, Completed, Daiichi Sankyo; results first posted 2011-02-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Olmesartan Comparison to Losartan in Hypertensive Subjects. Trials, record NCT00949884. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00949884
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Olmesartan Comparison to Losartan in Hypertensive Subjects
- NCT number
- NCT00949884
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 941 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Hypertension
- Interventions
- olmesartan medoxomil, Placebo, losartan potassium
- First posted
- 2009-07-30
- Last updated
- 2011-03-09
- Results first posted
- 2011-02-28
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | Day 0, Week 8 | The change from baseline in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit. |
| Secondary | Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | Day 0, Week 4 | The change from baseline in trough SSBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit. |
| Secondary | Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | Day 0, Week 8 | The change from baseline in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit. |
| Secondary | Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | Day 0, Week 4 | The change from baseline in trough SDBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit. |
| Other | Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | Week 4, Week 8 | The change from Week 4 in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit. |
| Other | Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | Week 4, Week 8 | The change from Week 4 in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit. |
| Other | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Week 4 | Percentage of participants who achieved the following goals: Systolic blood pressure: \<140 mmHg, \<135 mmHg, \<130 mmHg, \<120 mmHg Diastolic blood pressure: \<90 mmHg, \<85 mmHg, \<80 mmHg Blood pressure: \<140/90 mmHg, \<135/80 mmHg, \<130/80 mmHg |
| Other | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Week 8 | Percentage of participants who achieved the following goals: Systolic blood pressure: \<140 mmHg, \<135 mmHg, \<130 mmHg, \<120 mmHg Diastolic blood pressure: \<90 mmHg, \<85 mmHg, \<80 mmHg Blood pressure: \<140/90 mmHg, \<135/80 mmHg, \<130/80 mmHg, \<120/80 mmHg |
| Other | Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4 | Baseline, Week 4 | In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. |
| Other | Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8 | Baseline, Week 8 | In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | Day 0, Week 8 | The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | Day 0, Week 4 | The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | Day 0, Week 8 | The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | Day 0, Week 4 | The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward | mmHg | LEAST_SQUARES_MEAN |
| POST_HOC | Percentage of Participants Achieving Ambulatory Blood Pressure Goal of < 135/85 mmHg at Week 8 | Week 8 | Ambulatory Blood Pressure Monitoring (ABPM) Population: All participants in the Efficacy Population that had both valid (technically successful) baseline and Week 8 ambulatory blood pressure monitor data. A technically successful ABPM had at least 23 hours of ABPM data. | percentage of population | NUMBER |
| OTHER_PRE_SPECIFIED | Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | Week 4, Week 8 | The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward | mmHg | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | Week 4, Week 8 | The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward | mmHg | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Week 4 | Efficacy population. Last observation carried forward. Denominator is the number of participants who have seated cuff BP measurement in each treatment group at any visit during the entire randomized treatment phase. Participants randomized to placebo-olmesartan, the measurement is after at least one dose of olmesartan. | percentage of participants analyzed | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Week 8 | Efficacy population. Last observation carried forward. Denominator is the number of participants who have seated cuff BP measurement in each treatment group at any visit during the entire randomized treatment phase. Participants randomized to placebo-olmesartan, the measurement is after at least one dose of olmesartan. | percentage of participants analyzed | NUMBER |
| OTHER_PRE_SPECIFIED | Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4 | Baseline, Week 4 | The ABPM population was defined as all participants in the efficacy population that had valid (technically successful required at least 23 hours of ABPM data) baseline and Week 4 ABPM data. | mmHg | LEAST_SQUARES_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group166
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | Olmesartan | -9.8 | Standard Error 0.50 | mmHg | |
| Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | Combined Olmesartan | -9.7 | Standard Error 0.45 | mmHg | |
| Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | Losartan | -7.1 | Standard Error 0.45 | mmHg | |
| Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | Olmesartan | -12.3 | Standard Error 0.67 | mmHg | |
| Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | Combined Olmesartan | -12.0 | Standard Error 0.64 | mmHg | |
| Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | Losartan | -8.5 | Standard Error 0.64 | mmHg | |
| Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | Olmesartan | -13.6 | Standard Error 0.75 | mmHg | |
| Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | Combined Olmesartan | -13.6 | Standard Error 0.71 | mmHg | |
| Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | Losartan | -9.7 | Standard Error 0.71 | mmHg | |
| Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | Olmesartan | -9.0 | Standard Error 0.44 | mmHg |
1 to 10 of 166Source ClinicalTrials.gov
See all 166 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Olmesartan | 420 | |
| Overall Study | STARTED | Placebo Followed by Olmesartan | 52 | |
| Overall Study | STARTED | Losartan | 469 | |
| Overall Study | COMPLETED | Olmesartan | 370 | |
| Overall Study | COMPLETED | Placebo Followed by Olmesartan | 37 | |
| Overall Study | COMPLETED | Losartan | 411 | |
| Overall Study | NOT COMPLETED | Olmesartan | 50 | |
| Overall Study | NOT COMPLETED | Placebo Followed by Olmesartan | 15 | |
| Overall Study | NOT COMPLETED | Losartan | 58 |
Source ClinicalTrials.gov
Adverse events510
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 | Anaemia | Blood and lymphatic system disorders | Olmesartan | 0 | 420 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Followed by Olmesartan | 0 | 52 | |
| other | Anaemia | Blood and lymphatic system disorders | Losartan | 2 | 469 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Olmesartan | 0 | 420 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Placebo Followed by Olmesartan | 1 | 52 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Losartan | 0 | 469 | |
| other | Palpitations | Cardiac disorders | Olmesartan | 1 | 420 | |
| other | Palpitations | Cardiac disorders | Placebo Followed by Olmesartan | 0 | 52 | |
| other | Palpitations | Cardiac disorders | Losartan | 0 | 469 | |
| other | Tachycardia | Cardiac disorders | Olmesartan | 1 | 420 |
1 to 10 of 510Source ClinicalTrials.gov
See all 510 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Olmesartan | ||
| Total, all-cause mortality | Placebo Followed by Olmesartan | ||
| Total, all-cause mortality | Losartan | ||
| Total, other adverse events | Olmesartan | 133 | 420 |
| Total, other adverse events | Placebo Followed by Olmesartan | 21 | 52 |
| Total, other adverse events | Losartan | 148 | 469 |
| Total, serious adverse events | Olmesartan | 0 | 420 |
| Total, serious adverse events | Placebo Followed by Olmesartan | 0 | 52 |
| Total, serious adverse events | Losartan | 4 | 469 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22763801 | DERIVED |
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 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/NCT00949884
GET https://conductscience.org/api/trials/v1/NCT00949884/results?page=2