Trial · NCT00064792
Simvastatin Therapy in Smith-Lemli-Opitz Syndrome
NCT00064792, Phase 2, Completed, Forbes Porter, M.D.; results first posted 2014-06-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Simvastatin Therapy in Smith-Lemli-Opitz Syndrome. Trials, record NCT00064792. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00064792
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Simvastatin Therapy in Smith-Lemli-Opitz Syndrome
- NCT number
- NCT00064792
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Forbes Porter, M.D.
- Conditions
- Smith-Lemli-Opitz Syndrome
- Interventions
- Simvastatin Susp., OraPlus
- First posted
- 2003-07-14
- Last updated
- 2014-06-06
- Results first posted
- 2014-06-06
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Serum Cholesterol to Total Sterol Ratio | 1 year after therapy. | Total serum cholesterol (mg/dL) divided by the sum of all sterols (cholesterol plus its precursors, 7-dehydrocholesterol - 7DHC, and 8-dehydrocholesterol- 8DHC - in mg/dL). |
| Secondary | Cerebral Spinal Fluid Dehydrocholesterol to Total Sterol Ratio | 12 months | Percent of 7-dehydrocholesterol + 8-dehydrocholesterol as a fraction of the total sterols (cholesterol + 7-dehydrocholesterol + 8-dehydrocholesterol measured in cerebral spinal fluid |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Serum Cholesterol to Total Sterol Ratio | 1 year after therapy. | The number of participants was determined by the total number of participants to complete both phases of the trial (n=18). | percent total cholesterol | MEAN |
| SECONDARY | Cerebral Spinal Fluid Dehydrocholesterol to Total Sterol Ratio | 12 months | percent of total sterols | 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 |
|---|---|---|---|---|---|
| Serum Cholesterol to Total Sterol Ratio | Not Simvastatin | 90.82 | Standard Deviation 8.52 | percent total cholesterol | |
| Serum Cholesterol to Total Sterol Ratio | Simvastatin | 93.99 | Standard Deviation 5.36 | percent total cholesterol | |
| Cerebral Spinal Fluid Dehydrocholesterol to Total Sterol Ratio | Not Simvastatin | 5.898 | Standard Deviation 4.684 | percent of total sterols | |
| Cerebral Spinal Fluid Dehydrocholesterol to Total Sterol Ratio | Simvastatin | 5.154 | Standard Deviation 3.067 | percent of total sterols |
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 | Placebo Followed by Simvastatin | 13 | |
| Overall Study | STARTED | Simvastatin Followed by Placebo | 10 | |
| Overall Study | COMPLETED | Placebo Followed by Simvastatin | 8 | |
| Overall Study | COMPLETED | Simvastatin Followed by Placebo | 10 | |
| Overall Study | NOT COMPLETED | Placebo Followed by Simvastatin | 5 | |
| Overall Study | NOT COMPLETED | Simvastatin Followed by Placebo | 0 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| serious | Muscle Pain and Elevated CK | Musculoskeletal and connective tissue disorders | OraPlus | 1 | 23 | 1 |
| serious | Muscle Pain and Elevated CK | Musculoskeletal and connective tissue disorders | Simvastatin Susp | 0 | 10 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OraPlus | ||
| Total, all-cause mortality | Simvastatin Susp | ||
| Total, other adverse events | OraPlus | 0 | 23 |
| Total, other adverse events | Simvastatin Susp | 0 | 23 |
| Total, serious adverse events | OraPlus | 1 | 23 |
| Total, serious adverse events | Simvastatin Susp | 0 | 23 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| OraPlus vs Simvastatin Susp: 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/NCT00064792
GET https://conductscience.org/api/trials/v1/NCT00064792/registered