Coronary Heart DiseasePhase 1NCT00907998
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180
A Phase 1 study testing APL180 in people with Coronary Heart Disease, run by Novartis Pharmaceuticals at 11 sites in 5 countries.
Trial summary
The design of this study will enable an extensive evaluation of safety, tolerability, and PK-PD relationship following 4 weeks of dosing in patients with Coronary heart Disease Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- APL180
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 11 sitesin 5 countries
- Study dates
- Jun 2009to Oct 2009
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female CHD or CHD equivalent patients
- Body mass index (BMI) must be within the range of 20 to 35 kg/m2,
- Patient must have been on a stable statin therapy for >8 weeks prior to first dose except for the statin intolerant patients.
Who cannot join
- Pregnancy
- Significant illness within two weeks prior to dosing.
- Triglycerides ≥ 500 mg/dl (5.65 mmol/l)
- Uncontrolled hypertension
- Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety.
- Presence of NYHA Class III or IV chronic heart failure
- MI or angioplasty (including stenting), acute coronary syndrome (ACS), unstable angina or arterial embolic disease within 6 months prior to do Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
United States3 sites
Pinnacle Research Group
Anniston, Alabama, AL36207
Novartis Investigative Site
Philadelphia, Pennsylvania
Icon Clinical Research
San Antonio, Texas, 78230
Germany3 sites
Novartis Investigator Site
Mainz
Novartis Investigator Site
Mannheim
Novartis Investigator Site
Neuss
Israel3 sites
Novartis Investigator Site
Rehovot
Novartis Investigator Site
Tel Aviv
Novartis Investigator Site
Zrifin
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study in Patients With Coronary Heart Disease (CHD) to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Administration of APL180
The design of this study will enable an extensive evaluation of safety, tolerability, and PK-PD relationship following 4 weeks of dosing in patients with Coronary heart Disease
- Conditions
- Coronary Heart Disease
- Being tested
- APL180, Placebo
- Keywords
- Coronary heart disease, APL180
- Medical subject headings
- Coronary Disease
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 |
|---|---|---|
| APL180 (first dose level) | Experimental | Not described Receives: Drug: APL180 |
| APL180 (second dose level) | Experimental | Not described Receives: Drug: APL180 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of APL180
Measured: Throughout the study
Secondary outcomes (4)
Pharmacokinetics of APL180
Measured: Throughout the study
Evaluate effects of APL180 biomarkers
Measured: Throughout the study
Pharmacokinetic-pharmacodynamic relationship of APL180
Measured: Throughout the study
Effect of APL180 on exploratory biomarkers,
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907998
- Sponsor's protocol ID
- CAPL180A2210B
- Other IDs
- EudraCT 2009-010877-19
- Status last verified
- Nov 2009
- First submitted
- 22 May 2009
- Last updated
- 20 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study in Patients With Coronary Heart Disease (CHD) to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Administration of APL180
- ClinicalTrials.gov ID
- NCT00907998
- Acronym / sponsor ID
- CAPL180A2210B
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary heart disease, APL180
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Oct 2009 (actual)
- First posted
- 25 May 2009 (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.
The design of this study will enable an extensive evaluation of safety, tolerability, and PK-PD relationship following 4 weeks of dosing in patients with Coronary heart Disease
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| APL180 (first dose level) | Experimental | Drug: APL180 |
| APL180 (second dose level) | Experimental | Drug: APL180 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female CHD or CHD equivalent patients
- Body mass index (BMI) must be within the range of 20 to 35 kg/m2,
- Patient must have been on a stable statin therapy for >8 weeks prior to first dose except for the statin intolerant patients.
Key exclusion criteria (7 listed)
- Pregnancy
- Significant illness within two weeks prior to dosing.
- Triglycerides ≥ 500 mg/dl (5.65 mmol/l)
- Uncontrolled hypertension
- Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety.
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 | APL180 (first dose level) |
| APL180 | Drug | APL180 (second dose level) |
| Placebo | Drug | Placebo |
Primary outcome
Safety and tolerability of APL180
Time frame: Throughout the study
4 secondary outcomes
Pharmacokinetics of APL180
Time frame: Throughout the study
Evaluate effects of APL180 biomarkers
Time frame: Throughout the study
Pharmacokinetic-pharmacodynamic relationship of APL180
Time frame: Throughout the study
Effect of APL180 on exploratory biomarkers,
Time frame: Throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2009.
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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 Pharmaceuticals study director
Novartis Pharmaceuticals
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APL180 in people with Coronary Heart Disease, run by Novartis Pharmaceuticals at 11 sites in 5 countries.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 20 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Germany, Israel, Denmark, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability of APL180 (time frame: Throughout the study). 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 20 Nov 2009; AzTrials last refreshed its copy on 8 Nov 2026.