Trial · NCT00496834
LAAS (Losartan Anti-Atherosclerosis Study)(0954-330)(COMPLETED)
NCT00496834, Phase 4, Completed, Organon and Co; results first posted 2010-12-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. LAAS (Losartan Anti-Atherosclerosis Study)(0954-330)(COMPLETED). Trials, record NCT00496834. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00496834
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LAAS (Losartan Anti-Atherosclerosis Study)(0954-330)(COMPLETED)
- NCT number
- NCT00496834
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 201 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Hypertension
- Interventions
- losartan potassium, Comparator: carvedilol, Comparator: losartan (+) hydrochlorothiazide (HCTZ), Comparator: carvedilol (+) hydrochlorothiazide
- First posted
- 2007-07-04
- Last updated
- 2024-05-22
- Results first posted
- 2010-12-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Baseline and 24 Weeks | Analysis was performed in the modified intention to treat (mITT) population. |
| Primary | PWV Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Baseline and 24 Weeks | Analysis was performed in the per protocol (PP) population which additionally excludes certain protocol violations as described in the analysis plan. |
| Secondary | Systolic Blood Pressure (SBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Baseline and 24 weeks | |
| Secondary | Diastolic Blood Pressure (DBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Baseline and 24 weeks |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Baseline and 24 Weeks | Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94). Missing data were imputed by the last observation carried forward (LOCF) technique. | meters/second | MEAN |
| PRIMARY | PWV Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Baseline and 24 Weeks | Participants for analysis was per protocol (Number of patients: Losartan group was 54, Carvedilol group was 67). Missing data were imputed by the last observation carried forward (LOCF) technique. For the primary efficacy endpoints, Per protocol analysis approach was supplementary used. | meters/second | MEAN |
| SECONDARY | Systolic Blood Pressure (SBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Baseline and 24 weeks | Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94) Missing data were imputed by the last observation carried forward (LOCF) technique. | mm Hg | MEAN |
| SECONDARY | Diastolic Blood Pressure (DBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Baseline and 24 weeks | Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94) Missing data were imputed by the last observation carried forward (LOCF) technique. | mm Hg | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Losartan | 0.28 | Standard Deviation 1.29 | meters/second | |
| Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Carvedilol | -0.12 | Standard Deviation 1.55 | meters/second | |
| PWV Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Losartan | 0.16 | Standard Deviation 1.25 | meters/second | |
| PWV Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Carvedilol | -0.20 | Standard Deviation 1.50 | meters/second | |
| Systolic Blood Pressure (SBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Losartan | -15.08 | Standard Deviation 14.59 | mm Hg | |
| Systolic Blood Pressure (SBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Carvedilol | -14.81 | Standard Deviation 15.38 | mm Hg | |
| Diastolic Blood Pressure (DBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Losartan | -8.43 | Standard Deviation 9.29 | mm Hg | |
| Diastolic Blood Pressure (DBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug | Carvedilol | -7.81 | Standard Deviation 9.61 | mm Hg |
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 | Losartan | 101 | |
| Overall Study | STARTED | Carvedilol | 100 | |
| Overall Study | COMPLETED | Losartan | 83 | |
| Overall Study | COMPLETED | Carvedilol | 87 | |
| Overall Study | NOT COMPLETED | Losartan | 18 | |
| Overall Study | NOT COMPLETED | Carvedilol | 13 |
Source ClinicalTrials.gov
Adverse events152
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 | 8 | 101 | 8 |
| other | Headache | Nervous system disorders | Carvedilol | 9 | 100 | 12 |
| other | Dizziness | Nervous system disorders | Losartan | 5 | 101 | 5 |
| other | Dizziness | Nervous system disorders | Carvedilol | 3 | 100 | 3 |
| other | Dizziness postural | Nervous system disorders | Losartan | 0 | 101 | 0 |
| other | Dizziness postural | Nervous system disorders | Carvedilol | 2 | 100 | 2 |
| other | Cerebral infarction | Nervous system disorders | Losartan | 1 | 101 | 1 |
| other | Cerebral infarction | Nervous system disorders | Carvedilol | 0 | 100 | 0 |
| other | Hypoaesthesia | Nervous system disorders | Losartan | 0 | 101 | 0 |
| other | Hypoaesthesia | Nervous system disorders | Carvedilol | 1 | 100 | 1 |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Losartan | ||
| Total, all-cause mortality | Carvedilol | ||
| Total, other adverse events | Losartan | 35 | 101 |
| Total, other adverse events | Carvedilol | 51 | 100 |
| Total, serious adverse events | Losartan | 5 | 101 |
| Total, serious adverse events | Carvedilol | 6 | 100 |
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 vs Carvedilol: 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/NCT00496834
GET https://conductscience.org/api/trials/v1/NCT00496834/events?page=2