Trial · NCT01277822
Efficacy of Losartan + Amlodipine Compared to Amlodipine Alone in the Treatment of Uncontrolled High Blood Pressure (MK-0954F-399)
NCT01277822, Phase 4, Completed, Organon and Co; results first posted 2014-04-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy of Losartan + Amlodipine Compared to Amlodipine Alone in the Treatment of Uncontrolled High Blood Pressure (MK-0954F-399). Trials, record NCT01277822. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01277822
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Losartan + Amlodipine Compared to Amlodipine Alone in the Treatment of Uncontrolled High Blood Pressure (MK-0954F-399)
- NCT number
- NCT01277822
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 334 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Hypertension
- Interventions
- Losartan (+) amlodipine, Placebo to match losartan/amlodipine tablets, Amlodipine camsylate, Placebo to match amlodipine
- First posted
- 2011-01-17
- Last updated
- 2024-06-20
- Results first posted
- 2014-04-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 | Baseline and Week 8 | Diastolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded. |
| Secondary | Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4 | Baseline and Week 4 | Diastolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded. |
| Secondary | Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 | Baseline and Week 8 | Systolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded. |
| Secondary | Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4 | Baseline and Week 4 | Systolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded. |
| Secondary | Percentage of Participants Who Achieve Target Blood Pressure at Week 8 | Week 8 | Participants were evaluated at Week 8 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) \<90mmHg or sitting systolic BP (sitSBP) \<140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline. |
| Secondary | Percentage of Participants Who Achieve Target Blood Pressure at Week 4 | Week 4 | Participants were evaluated at Week 4 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) \<90mmHg or sitting systolic BP (sitSBP) \<140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline. |
| Secondary | Percentage of Participants Who Had Peripheral Edema During the Study | up to 8 weeks | A pitting assessment of edema on both legs was performed at baseline and throughout the study. Participants were assessed in a seated position with both feet extended and the right ankle in a neutral dorsiflexion position. The index finger was pressed firmly over the bony prominence approximately 3cm proximal to the midpoint of the medial malleolus of the right ankle and will be held for three seconds. Presence of a residual indentation in the area after releasing pressure on the index finger was considered positive for pitting edema. |
| Secondary | Change From Baseline in Ankle Circumference at Week 8 | Baseline and Week 8 | Each ankle was marked with a semi-permanent marker at approximately 3 cm proximal to the midpoint of the medial malleolus to aid consistency in the performance of the measurements. Ankle circumference was measured in both ankles at baseline and Week 8 using a tension controlled tape to minimize error. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 | Baseline and Week 8 | Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement. | mmHg | MEAN |
| SECONDARY | Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4 | Baseline and Week 4 | Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement. | mmHg | MEAN |
| SECONDARY | Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 | Baseline and Week 8 | Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement. | mmHg | MEAN |
| SECONDARY | Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4 | Baseline and Week 4 | Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement. | mmHg | MEAN |
| SECONDARY | Percentage of Participants Who Achieve Target Blood Pressure at Week 8 | Week 8 | Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve Target Blood Pressure at Week 4 | Week 4 | Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Had Peripheral Edema During the Study | up to 8 weeks | Safety Set defined as all participants who received at least 1 dose of study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Ankle Circumference at Week 8 | Baseline and Week 8 | All participants who received at least 1 dose of study drug and had available data for ankle circumference. | mm | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 | Losartan/Amlodipine | -10.1 | Standard Deviation 7.6 | mmHg | |
| Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 | Amlodipine | -8.8 | Standard Deviation 7.8 | mmHg | |
| Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4 | Losartan/Amlodipine | -9.3 | Standard Deviation 7.8 | mmHg | |
| Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4 | Amlodipine | -10.0 | Standard Deviation 7.9 | mmHg | |
| Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 | Losartan/Amlodipine | -15.0 | Standard Deviation 12.1 | mmHg | |
| Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 | Amlodipine | -12.7 | Standard Deviation 10.7 | mmHg | |
| Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4 | Losartan/Amlodipine | -12.5 | Standard Deviation 13.2 | mmHg | |
| Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4 | Amlodipine | -12.3 | Standard Deviation 10.9 | mmHg | |
| Percentage of Participants Who Achieve Target Blood Pressure at Week 8 | Losartan/Amlodipine | 63.0 | Percentage of Participants | ||
| Percentage of Participants Who Achieve Target Blood Pressure at Week 8 | Amlodipine | 58.8 | Percentage of Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Losartan/Amlodipine | 168 | |
| Overall Study | STARTED | Amlodipine | 166 | |
| Overall Study | COMPLETED | Losartan/Amlodipine | 153 | |
| Overall Study | COMPLETED | Amlodipine | 155 | |
| Overall Study | NOT COMPLETED | Losartan/Amlodipine | 15 | |
| Overall Study | NOT COMPLETED | Amlodipine | 11 |
Source ClinicalTrials.gov
Adverse events30
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 | Losartan 100mg/Amlodipine 5mg | 6 | 168 | 6 |
| other | HEADACHE | Nervous system disorders | Amlodipine 10mg | 11 | 166 | 11 |
| serious | ANGINA UNSTABLE | Cardiac disorders | Losartan 100mg/Amlodipine 5mg | 1 | 168 | 1 |
| serious | ANGINA UNSTABLE | Cardiac disorders | Amlodipine 10mg | 0 | 166 | 0 |
| serious | ASTHENIA | General disorders | Losartan 100mg/Amlodipine 5mg | 0 | 168 | 0 |
| serious | ASTHENIA | General disorders | Amlodipine 10mg | 1 | 166 | 1 |
| serious | ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | Losartan 100mg/Amlodipine 5mg | 3 | 168 | 3 |
| serious | ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | Amlodipine 10mg | 2 | 166 | 2 |
| serious | EXCORIATION | Injury, poisoning and procedural complications | Losartan 100mg/Amlodipine 5mg | 0 | 168 | 0 |
| serious | EXCORIATION | Injury, poisoning and procedural complications | Amlodipine 10mg | 1 | 166 | 1 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Losartan 100mg/Amlodipine 5mg | ||
| Total, all-cause mortality | Amlodipine 10mg | ||
| Total, other adverse events | Losartan 100mg/Amlodipine 5mg | 6 | 168 |
| Total, other adverse events | Amlodipine 10mg | 11 | 166 |
| Total, serious adverse events | Losartan 100mg/Amlodipine 5mg | 6 | 168 |
| Total, serious adverse events | Amlodipine 10mg | 5 | 166 |
Source ClinicalTrials.gov
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Losartan 100mg/Amlodipine 5mg vs Amlodipine 10mg: 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/NCT01277822
GET https://conductscience.org/api/trials/v1/NCT01277822/events?page=2