Trial · NCT00455403
Atheroma Reduction With Chloroquine in Patients With the Metabolic Syndrome (ARCH-MS)
NCT00455403, Not applicable, Completed, Washington University School of Medicine; results first posted 2021-06-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Atheroma Reduction With Chloroquine in Patients With the Metabolic Syndrome (ARCH-MS). Trials, record NCT00455403. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00455403
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Atheroma Reduction With Chloroquine in Patients With the Metabolic Syndrome (ARCH-MS)
- NCT number
- NCT00455403
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 357 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Metabolic Syndrome X, Overweight, Hypertension, Dyslipidemias, Prediabetic State
- Interventions
- Chloroquine, Placebo Comparator
- First posted
- 2007-04-03
- Last updated
- 2021-12-15
- Results first posted
- 2021-06-25
- Limitations and caveats
One limitation of the study is that it may have been underpowered to detect a difference in CIMT. Sample size estimates at the time of initiation of these studies were based on reports showing that insulin sensitizers had effects on CIMT with groups of 31-57 subjects, but subsequent work indicated the need for larger sample sizes.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Carotid Intima-media Thickness From Baseline to Year 1 | Measured at baseline and year 1 | A noninvasive predictor of cardiovascular events, Carotid artery intima-media thickness (CIMT) was measured from B-mode images by a single sonographer using standard approaches |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Carotid Intima-media Thickness From Baseline to Year 1 | Measured at baseline and year 1 | Intent to treat | millmeter | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Carotid Intima-media Thickness From Baseline to Year 1 | Chloroquine Subjects | Baseline | 0.766 | Standard Deviation 0.17 | millmeter |
| Change in Carotid Intima-media Thickness From Baseline to Year 1 | Placebo Subjects | Baseline | 0.765 | Standard Deviation 0.13 | millmeter |
| Change in Carotid Intima-media Thickness From Baseline to Year 1 | Chloroquine Subjects | Year 1 | 0.758 | Standard Deviation 0.16 | millmeter |
| Change in Carotid Intima-media Thickness From Baseline to Year 1 | Placebo Subjects | Year 1 | 0.768 | Standard Deviation 0.11 | millmeter |
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 | Chloroquine Subjects | 59 | |
| Overall Study | STARTED | Placebo Subjects | 57 | |
| Overall Study | COMPLETED | Chloroquine Subjects | 56 | |
| Overall Study | COMPLETED | Placebo Subjects | 51 | |
| Overall Study | NOT COMPLETED | Chloroquine Subjects | 3 | |
| Overall Study | NOT COMPLETED | Placebo Subjects | 6 |
Source ClinicalTrials.gov
Adverse events24
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 | Infections | Infections and infestations | Chloroquine Subjects | 39 | 59 | 51 |
| other | Infections | Infections and infestations | Placebo Subjects | 37 | 57 | 42 |
| other | allergy/immunology | Immune system disorders | Chloroquine Subjects | 5 | 59 | 51 |
| other | allergy/immunology | Immune system disorders | Placebo Subjects | 10 | 57 | 42 |
| other | CNS | Nervous system disorders | Chloroquine Subjects | 5 | 59 | 51 |
| other | CNS | Nervous system disorders | Placebo Subjects | 3 | 57 | 57 |
| other | Psychiatric | Psychiatric disorders | Chloroquine Subjects | 5 | 59 | 51 |
| other | Psychiatric | Psychiatric disorders | Placebo Subjects | 6 | 57 | 57 |
| other | ocular | Eye disorders | Chloroquine Subjects | 16 | 59 | 51 |
| other | ocular | Eye disorders | Placebo Subjects | 10 | 57 | 57 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chloroquine Subjects | 0 | 59 |
| Total, all-cause mortality | Placebo Subjects | 0 | 57 |
| Total, other adverse events | Chloroquine Subjects | 39 | 59 |
| Total, other adverse events | Placebo Subjects | 37 | 57 |
| Total, serious adverse events | Chloroquine Subjects | 5 | 59 |
| Total, serious adverse events | Placebo Subjects | 2 | 57 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P50HL083762 | SCCOR in Metabolic Syndrome and Vascular Disease | SEMENKOVICH, CLAY F. | WASHINGTON UNIVERSITY | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2006 to 2010 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Chloroquine Subjects vs Placebo Subjects: deaths from any cause | Trial comparisons |
| Chloroquine Subjects vs Placebo Subjects: serious adverse events | 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/NCT00455403
GET https://conductscience.org/api/trials/v1/NCT00455403/events?page=2