HyperlipidemiaPhase 2/3ARM-PLUS-LDLNCT01562080
Combined Effects of Bioactive Compounds in Lipid Profile
A Phase 2/3 study testing Armolipid Plus in people with Hyperlipidemia and Low-density-lipoprotein-type, run by Rottapharm Spain at 1 site in Spain.
Trial summary
The aim of this study is to demonstrate whether, along with dietary recommendations, Armolipid Plus ® can improve the profile of patients with elevated plasma LDL-C acting as a change of lifestyle therapy (TLC) according to the definition of Adult Treatment Panel III (ATP III) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemia, Low-density-lipoprotein-type, Elevated Triglycerides
- What is being tested?
- Armolipid Plus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2012to Oct 2012
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients > 18 years old
- LDL-c plasma levels ≥130 mg/dL and ≤ 189 mg/dL
- Patients not requiring lipid-lowering drug treatment according to ATPIII guidelines,that do not have cardiovascular disease, stroke or intermittent claudication, diabetes mellitus, renal or Patients who have demonstrated effects or contraindications to lipid-lowering drug therapy (in this case, treatment should be discontinued 1 month before baseline.
- Signed and dated informed consent before any study specific procedure.
Who cannot join
- Patients on drug therapy to reduce LDL-C, for example, statins, bile acid sequestrants, nicotinic acid, fibrates or similar (up to 1 month before baseline).
- History of cardiovascular disease, stroke or intermittent claudication.
- Diabetes mellitus (at least 2 blood fasting glucose greater than 126 mg / dL).
- Having taken any functional food with sterols, stanols or similar or any nutraceutical with lipid-lowering effects during the previous 7 days.
- Plasma levels of triglycerides > 350 mg/dl
- Diagnosis of familial hypercholesterolemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Effects of Bioactive Compounds (ARMOLIPID PLUS ®) on Lipid Profile and Clinical Criteria of Metabolic Syndrome in Patients With Serum Elevated LDL-C
The aim of this study is to demonstrate whether, along with dietary recommendations, Armolipid Plus ® can improve the profile of patients with elevated plasma LDL-C acting as a change of lifestyle therapy (TLC) according to the definition of Adult Treatment Panel III (ATP III)
Read the detailed description
Recently reported that the combination of extract of red yeast rice policosanol composed, berberine, folic acid and coenzyme Q10 (Armolipid Plus ®, Rottapharm) produced a significant improvement in lipid profile in patients with moderately elevated cholesterol levels of low density lipoprotein (LDL-C) plasma.
Taking into account the potential effect of Armolipid Plus ® on the lipid profile, it is important to investigate the effectiveness in the field of cardiovascular prevention to define its position in prevention programs.
- Being tested
- Armolipid Plus, placebo
- Keywords
- hyperlipidemia, metabolic syndrome, yeast red, berberine, policosanol, astaxanthin
- Medical subject headings
- Hyperlipidemias, Hypertriglyceridemia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Armolipid PlusDietary supplement
one tablet per day during 12 weeks
placeboDietary supplement
one tablet per day during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement | Experimental | red yeast, astaxanthin, berberine, policosanol, coenzyme Q10, folic acid Receives: Dietary Supplement: Armolipid Plus |
| microcrystalline cellulose | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
investigate whether the addition of Armolipid Plus ® decreases by 20% LDL-C levels compared to baseline in patients with initial levels of LDL-C ≥ 130 mg / dL.
Measured: twelve weeks
Secondary outcomes (3)
Cardiovascular risk (according to the Framingham tables).
Measured: twelve weeks
Criteria for Metabolic Syndrome
Measured: twelve weeks
Levels of triglycerides and cholesterol high density lipoprotein (HDL-C).
Measured: twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rottapharm Spain
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centro Tecnológico de Nutrición y Salud
- Responsible party
- Sponsor
- Investigators
- Rosa Solà, MD PhD, Study director, Hosp. Universitari Sant Joan de Reus (Tarragona)Jesús Millán, MD PhD, Principal investigator, Hosp. Universitario Gregorio Marañón (Madrid)José R Calabuig, MD PhD, Principal investigator, Hosp. Universitario La Fe (Valencia)José Villar, MD PhD, Principal investigator, Hosp. Universitario Virgen del Rocío (Sevilla)José Puzo, MD PhD, Principal investigator, Hosp. Universitario San Jorge (Huesca)Angel Brea, MD, Principal investigator, Hosp. Universitario San Pedro ( Logroño)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562080
- Sponsor's protocol ID
- ARM-PLUS-LDL
- Acronym
- ARM-PLUS-LDL
- Status last verified
- Feb 2013
- First submitted
- 21 Mar 2012
- Last updated
- 28 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Sola R, Valls RM, Puzo J, Calabuig JR, Brea A, Pedret A, Morina D, Villar J, Millan J, Anguera A. Effects of poly-bioactive compounds on lipid profile and body weight in a moderately hypercholesterolemic population with low cardiovascular disease risk: a multicenter randomized trial. PLoS One. 2014 Aug 1;9(8):e101978. doi: 10.1371/journal.pone.0101978. eCollection 2014.
PubMed 25084280
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Bioactive Compounds (ARMOLIPID PLUS ®) on Lipid Profile and Clinical Criteria of Metabolic Syndrome in Patients With Serum Elevated LDL-C
- ClinicalTrials.gov ID
- NCT01562080
- Acronym / sponsor ID
- ARM-PLUS-LDL / ARM-PLUS-LDL
- Keywords
- hyperlipidemia, metabolic syndrome, yeast red, berberine, policosanol, astaxanthin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Rottapharm SpainIndustry (pharma, biotech, devices)
- Collaborators
- Centro Tecnológico de Nutrición y Salud
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 23 Mar 2012 (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 aim of this study is to demonstrate whether, along with dietary recommendations, Armolipid Plus ® can improve the profile of patients with elevated plasma LDL-C acting as a change of lifestyle therapy (TLC) according to the definition of Adult Treatment Panel III (ATP III)
Detailed description
Recently reported that the combination of extract of red yeast rice policosanol composed, berberine, folic acid and coenzyme Q10 (Armolipid Plus ®, Rottapharm) produced a significant improvement in lipid profile in patients with moderately elevated cholesterol levels of low density lipoprotein (LDL-C) plasma.
Taking into account the potential effect of Armolipid Plus ® on the lipid profile, it is important to investigate the effectiveness in the field of cardiovascular prevention to define its position in prevention programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement | Experimental | Dietary Supplement: Armolipid Plusred yeast, astaxanthin, berberine, policosanol, coenzyme Q10, folic acid |
| microcrystalline cellulose | Placebo comparator | Dietary Supplement: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients > 18 years old
- LDL-c plasma levels ≥130 mg/dL and ≤ 189 mg/dL
- Patients not requiring lipid-lowering drug treatment according to ATPIII guidelines,that do not have cardiovascular disease, stroke or intermittent claudication, diabetes mellitus, renal or Patients who have demonstrated effects or contraindications to lipid-lowering drug therapy (in this case, treatment should be discontinued 1 month before baseline.
- Signed and dated informed consent before any study specific procedure.
Key exclusion criteria (6 listed)
- Patients on drug therapy to reduce LDL-C, for example, statins, bile acid sequestrants, nicotinic acid, fibrates or similar (up to 1 month before baseline).
- History of cardiovascular disease, stroke or intermittent claudication.
- Diabetes mellitus (at least 2 blood fasting glucose greater than 126 mg / dL).
- Having taken any functional food with sterols, stanols or similar or any nutraceutical with lipid-lowering effects during the previous 7 days.
- Plasma levels of triglycerides > 350 mg/dl
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 |
|---|---|---|
| Armolipid Plusone tablet per day during 12 weeks | Dietary supplement | Dietary supplement |
| placeboone tablet per day during 12 weeks | Dietary supplement | microcrystalline cellulose |
Primary outcome
investigate whether the addition of Armolipid Plus ® decreases by 20% LDL-C levels compared to baseline in patients with initial levels of LDL-C ≥ 130 mg / dL.
Time frame: twelve weeks
3 secondary outcomes
Cardiovascular risk (according to the Framingham tables).
Time frame: twelve weeks
Criteria for Metabolic Syndrome
Time frame: twelve weeks
Levels of triglycerides and cholesterol high density lipoprotein (HDL-C).
Time frame: twelve weeks
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 28 Feb 2013.
- Derived from this study: PubMed 25084280Sola R, Valls RM, Puzo J, Calabuig JR, Brea A, Pedret A, Morina D, Villar J, Millan J, Anguera A. Effects of poly-bioactive compounds on lipid profile and body weight in a moderately hypercholesterolemic population with low cardiovascular disease risk: a multicenter randomized trial. PLoS One. 2014 Aug 1;9(8):e101978. doi: 10.1371/journal.pone.0101978. eCollection 2014.
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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.
Rosa Solà, MD PhD study director
Hosp. Universitari Sant Joan de Reus (Tarragona)
Jesús Millán, MD PhD principal investigator
Hosp. Universitario Gregorio Marañón (Madrid)
José R Calabuig, MD PhD principal investigator
Hosp. Universitario La Fe (Valencia)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Armolipid Plus in people with Hyperlipidemia and Low-density-lipoprotein-type, run by Rottapharm Spain at 1 site in Spain.
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 4 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: finished, as of the sponsor's last update on 28 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
investigate whether the addition of Armolipid Plus ® decreases by 20% LDL-C levels compared to baseline in patients with initial levels of LDL-C ≥ 130 mg / dL. (time frame: twelve weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01562080, which also lists 1 linked publication.
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 28 Feb 2013.