Familial HypercholesterolemiaPhase 2NCT00751608
Effect of APL180 on Endothelial Function in Familial Hypercholesterolemia Patients
A Phase 2 study testing APL180 in people with Familial Hypercholesterolemia, run by Novartis Pharmaceuticals.
Trial summary
This study will evaluate the effect of APL180 on endothelial function measured by forearm venous occlusion plethysmography in patients with familial hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Familial Hypercholesterolemia
- What is being tested?
- APL180
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Feb 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed presence of familial hypercholesterolemia
- Women must be sterilized or post-menopausal
Who cannot join
- Smoking an average of greater than 10 cigarettes per day
- History of cardiac events
- Very low or high body weight
- Treatment with fibrates or niacin
- High blood triglyceride levels
- Other protocol-defined inclusion/exclusion criteria may apply.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Ascending Dose Study to Evaluate the Effect of APL180 on Endothelial Function in Patients With Familial Hypercholesterolemia
This study will evaluate the effect of APL180 on endothelial function measured by forearm venous occlusion plethysmography in patients with familial hypercholesterolemia.
- Conditions
- Familial Hypercholesterolemia
- Being tested
- APL180, Placebo
- Keywords
- Familial hypercholesterolemia, endothelial function, venous occlusion plethysmography, forearm blood flow, ApoAI-mimetic, endothelial dependent vasodilation
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APL180Drug
APL180Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: APL180 |
| 2 | Active comparator | Not described Receives: Drug: APL180 |
| 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in forearm blood flow during each treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study startSep 2006
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Novartis Investigator Site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751608
- Sponsor's protocol ID
- CAPL180A2207
- Status last verified
- Sep 2016
- First submitted
- 11 Sep 2008
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Ascending Dose Study to Evaluate the Effect of APL180 on Endothelial Function in Patients With Familial Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00751608
- Acronym / sponsor ID
- CAPL180A2207
- Conditions
- Familial Hypercholesterolemia
- Keywords
- Familial hypercholesterolemia, endothelial function, venous occlusion plethysmography, forearm blood flow, ApoAI-mimetic, endothelial dependent vasodilation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 12 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effect of APL180 on endothelial function measured by forearm venous occlusion plethysmography in patients with familial hypercholesterolemia.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: APL180 |
| 2 | Active comparator | Drug: APL180 |
| 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Confirmed presence of familial hypercholesterolemia
- Women must be sterilized or post-menopausal
Key exclusion criteria (6 listed)
- Smoking an average of greater than 10 cigarettes per day
- History of cardiac events
- Very low or high body weight
- Treatment with fibrates or niacin
- High blood triglyceride levels
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APL180 | Drug | 1 |
| APL180 | Drug | 2 |
| Placebo | Drug | 3 |
Primary outcome
Change in forearm blood flow during each treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis principal investigator
Novartis Investigator Site
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing APL180 in people with Familial Hypercholesterolemia, run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in forearm blood flow during each treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2016.