Atherogenic DyslipidemiaPhase 4NCT03615534
Extended Release Niacin and Fenofibrate for the Treatment of Atherogenic Dyslipidemia in Obese Females
A Phase 4 study testing Therapeutic Lifestyle Changes, Fenofibrate and Wax Matrix Extended Release Niacin (WMER Niacin) in people with Atherogenic Dyslipidemia and Obesity Associated Disorder, run by Lewai Sharki Abdulaziz, MSc PhD at 2 sites in Iraq.
Trial summary
Atherogenic Dyslipidemia (AD) is a risk-conferring lipid/lipoprotein profile that comprises a higher proportion of small LDL particles, reduced HDL-C, and increased triglycerides. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Atherogenic Dyslipidemia, Obesity Associated Disorder
- What is being tested?
- Therapeutic Lifestyle Changes, Fenofibrate and Wax Matrix Extended Release Niacin (WMER Niacin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 2 sitesIraq
- Study dates
- 1 Oct 2014to 30 Oct 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- BMI≥30 kg/m2.
- Conventional diagnosis of atherogenic dyslipidemia, confirmed by a fasting serum TG more than150 mg/dl coincide with an HDL-C of less than 50 mg/dl.
Who cannot join
- The use of any antilipidemic medication.
- Findings suggestive for renal dysfunction (eGFR˂60ml/min per 1.73 m2).
- Findings suggestive for hepatic insufficiency (ALT and/or AST˃2ULN).
- Clinical or laboratory findings suggestive for thyroid dysfunction.
- Established diagnosis of Diabetes Mellitus.
- History of gout, hyperuricemia, or on hypouricemic agents.
Show all 9Show fewer
- Active peptic ulcer.
- Pregnancy, or nursing mothers.
- Alcohol or tobacco consumption.
Trial locations and contacts
2 sites in 1 country.
Iraq2 sites
Al Kindy College of Medicine, University of Baghdad
Baghdad, 10045
Lewai S Abdulaziz
Baghdad, 10045
About this study
Official title: Efficacy and Safety of Extended Release Niacin-Fenofibrate Combination and Monotherapy for the Treatment of Atherogenic Dyslipidemia in Obese Females
Atherogenic Dyslipidemia (AD) is a risk-conferring lipid/lipoprotein profile that comprises a higher proportion of small LDL particles, reduced HDL-C, and increased triglycerides. It is characteristically seen in patients with obesity, metabolic syndrome, insulin resistance, and type 2 diabetes mellitus and has emerged as an important marker for the increased cardiovascular disease (CVD) risk observed in these populations.
Optimal cardiovascular risk reduction in patients exhibiting the lipid triad of AD requires integrated pharmacotherapy to normalize HDL-C, Triglyceride (TG) and LDL-C levels. Recent studies have focused on optimizing treatment for AD and compare the efficacy and tolerability of combined lipid-altering drug based therapies, however, an optimal pharmacologic approach has not yet been established.
The present study was intended to evaluate the restorative efficacy of Extended Release Niacin (ER Niacin) and Fenofibrate as mono and combination therapies , as well as their safety and tolerability in females with obesity-induced AD.
Read the detailed description
Study Setting:
The present study is a single blinded placebo-controlled randomized clinical trial, in which target individuals were obese females (BMI≥30 kg/m2), within the age of 20-60 years, attending the Obesity research and therapy unit of Al-Kindy College of Medicine, University of Baghdad (Baghdad, Iraq), throughout the period from 1st October 2014 to 15th March 2015.
Study Protocol:
Target individuals with fulfill devoid of exclusion criteria, were further screened and only candidates with conventional diagnosis of AD, as confirmed by a fasting serum TG >150 mg/dl coincide with an HDL-C of less than 50 mg/dl, were considered to be enrolled. Finally, and successive to a comprehensible concise for the expected benefits and side effects on top of the commitment to the entire protocol, eligible candidates settled for participation were provided with a written informed consent.
Enrollment:
- Therapeutic Lifestyle Changes (TLC) Run-in Period: Each and every eligible candidate was enrolled in a four-week TLC run-in (or lead-in) period to exclude responders and to obtain baseline data for non-responders prior to randomization.
- Randomization and Treatment Allocation: TLC non-responders with persistent AD were randomly allocated to one of the four treatment arms. In order to ensure a periodical balance among all study groups in the course of treatment allocation, permuted-block randomization with a block size of four was implemented and the system produced by this approach was adopted for the sequential random assignment of patients to treatment arms. .
Discontinuation of Treatment:
Although the absence of published consensus on drug discontinuation in the face of laboratory abnormalities has permitted a spectrum of indefinite decisions, mainly driven by clinical experience, clinical status and tolerability of the patient. For the present study discontinuation of treatment is considered if:
- Adverse events including flushing, nausea, vomiting, muscle pain, or dizziness turn sever enough to surpass patient's tolerability.
- Estimated glomerular filtration rate (eGFR) is reduced to ˂ 60ml/min per 1.73 m2 indicating renal insufficiency.
- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) increased to>3 Upper Limit of Normal (ULN) with the appearance of nausea, vomiting, fatigue, right upper quadrant pain or tenderness, fever, and/or rash.
- Serum uric acid exceeds the critical value of 6mg/dl.
Assessment of Treatments Responses:
Responses to the different treatments arms, in terms of efficacy and safety, are assessed by analyzing clinical and laboratory data collected at each visit over the entire course of the study, including a thorough medical history and previous medication records.
Statistical Analysis:
All statistical analyses were executed via the statistical package SPSS version 17.0 (SPSS, Inc.). Prior to analysis, Shapiro-Wilk test was used for assessing the normality of distributions for continuous variables, with the data expressed as the mean ± standard error (SE). Analysis of variance (ANOVA) was applied to compare the means of baseline characteristics among different treatments groups. Comprising the influence of the baseline level as a covariate, analysis of covariance (ANCOVA), embracing the least significant difference (LSD) for pair-wise comparison, was applied to assess treatment effects and safety profiles among different arms. Results were evaluated in terms of adjusted end line levels and percent changes from baseline levels. Multivariate Analysis of Covariance (MANCOVA), on the other hand, with further adjustments for relevant covariates was conducted whenever needed. Probability of less than 0.05 was considered statistically significant.
- Being tested
- Therapeutic Lifestyle Changes, Placebo, Fenofibrate, Wax Matrix Extended Release Niacin (WMER Niacin)
- Keywords
- Extended Release Niacin, Fenofibrate, treatment, Obesity, Atherogenic Dyslipidemia
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Lifestyle ChangesOther
Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
PlaceboOther
FenofibrateDrug
Also called Lipanthyl
Wax Matrix Extended Release Niacin (WMER Niacin)Dietary supplement
Also called ENDUR-ACIN®
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks. Receives: Other: Therapeutic Lifestyle Changes; Other: Placebo |
| Fenofibrate Monotherapy | Active comparator | Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks. Receives: Other: Therapeutic Lifestyle Changes; Drug: Fenofibrate |
| WMER Niacin Monotherapy | Active comparator | Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks. Receives: Other: Therapeutic Lifestyle Changes; Dietary Supplement: Wax Matrix Extended Release Niacin (WMER Niacin) |
| Combination Therapy | Active comparator | Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks. Receives: Other: Therapeutic Lifestyle Changes; Drug: Fenofibrate; Dietary Supplement: Wax Matrix Extended Release Niacin (WMER Niacin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes Serum Triglyceride Levels
Assessments involve the measurement of serum Triglyceride (TG) level.
Measured: Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments.
Changes in Serum Lipoprotein Cholesterol Levels
Assessments involve the measurement of serum Total (TC), High density lipoprotein (HDL-C) and direct Low density lipoprotein (d-LDL-C) cholesterol levels.
Serum non HDL-C levels is calculated by subtracting HDL-C from TC. Serum Remnant cholesterol (RC) is calculated by subtracting HDL-C and d-LDL-C from TC.
Measured: Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments.
Changes in Serum Apolipoprotein Levels
Assessments involve the measurement of serum Apolipoprotein A1 (Apo A1) and B (Apo B) levels.
Measured: Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments.
Secondary outcomes (6)
Changes in Serum Fasting Glucose Levels.
Assessments involve the measurement of serum fasting glucose levels.
Measured: Changes from baseline were assessed at the end eighth week of treatments.
Changes in Estimated Glomerular Filtration Rate (eGFR)
Assessments involve the measurement of serum creatinine which is used to calculate eGFR using the CKD-EPI equation (2009) .
Measured: Changes from baseline were assessed at the end of the eighth week of treatments.
Changes in Serum Uric Acid Levels
Assessments involve the measurement of serum uric acid levels
Measured: Changes from baseline were assessed at the end of the eighth week of treatments.
Changes in Serum Enzymes Levels
Assessments involve the measurement of serum enzymes including Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) levels.
Measured: Changes from baseline were assessed at the end of the eighth week of treatments.
Changes in Systolic and Diastolic Blood Pressure
Assessments involve the measurement of systolic and diastolic blood pressure. Patients were allowed to rest for 15 minutes in sitting position, and Walgreens Homedics WGNBPA-540 upper arm blood pressure monitor (Walgreens, China), was used for the measurement of blood pressure. Three consecutive readings were taken at 1 minute interval, and systolic and diastolic blood pressure were calculated as the mean of the last two readings.
Measured: Changes from baseline were assessed at the end of the eighth week of treatments.
Adverse Events
Assessments comprise the total number of participants complicating and reporting muscle pain,flushing, nausea, vomiting, and dizziness.
As part of the complete safety profile of each arm,other specific reported adverse event are presented in the Adverse Event Module.
Measured: Changes from baseline were assessed at the end of the eighth week of treatments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Oct 2014
- Primary completion30 Jun 2015
- Study completion30 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atherogenic DyslipidemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lewai Sharki Abdulaziz, MSc PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Kindy College of Medicine
- Responsible party
- Sponsor-investigator, Lewai Sharki Abdulaziz, MSc PhD, Al-Kindy College of Medicine
- Investigators
- Lewai S Abdulaziz, MSc PhD, Study chair, Al-Kindy college of Medicine, University of BaghdadMay S Al-Sabbagh, MSc, Study chair, College of Pharmacy, University of BaghdadMarwah S Attar, MSc, Study director, College of Pharmacy, University of BaghdadFaris A Khazaal, FRCP, Principal investigator, Al-Kindy college of Medicine, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615534
- Sponsor's protocol ID
- 1 Al-KindyCM
- Status last verified
- Jan 2024
- First submitted
- 27 Jul 2018
- Last updated
- 24 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (table, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Extended Release Niacin-Fenofibrate Combination and Monotherapy for the Treatment of Atherogenic Dyslipidemia in Obese Females
- ClinicalTrials.gov ID
- NCT03615534
- Acronym / sponsor ID
- 1 Al-KindyCM
- Keywords
- Extended Release Niacin, Fenofibrate, treatment, Obesity, Atherogenic Dyslipidemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Lewai Sharki Abdulaziz, MSc PhDUniversity, hospital or other
- Collaborators
- Al-Kindy College of Medicine
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Oct 2015 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Posted 12 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atherogenic Dyslipidemia (AD) is a risk-conferring lipid/lipoprotein profile that comprises a higher proportion of small LDL particles, reduced HDL-C, and increased triglycerides. It is characteristically seen in patients with obesity, metabolic syndrome, insulin resistance, and type 2 diabetes mellitus and has emerged as an important marker for the increased cardiovascular disease (CVD) risk observed in these populations.
Optimal cardiovascular risk reduction in patients exhibiting the lipid triad of AD requires integrated pharmacotherapy to normalize HDL-C, Triglyceride (TG) and LDL-C levels. Recent studies have focused on optimizing treatment for AD and compare the efficacy and tolerability of combined lipid-altering drug based therapies, however, an optimal pharmacologic approach has not yet been established.
The present study was intended to evaluate the restorative efficacy of Extended Release Niacin (ER Niacin) and Fenofibrate as mono and combination therapies , as well as their safety and tolerability in females with obesity-induced AD.
Detailed description
Study Setting:
The present study is a single blinded placebo-controlled randomized clinical trial, in which target individuals were obese females (BMI≥30 kg/m2), within the age of 20-60 years, attending the Obesity research and therapy unit of Al-Kindy College of Medicine, University of Baghdad (Baghdad, Iraq), throughout the period from 1st October 2014 to 15th March 2015.
Study Protocol:
Target individuals with fulfill devoid of exclusion criteria, were further screened and only candidates with conventional diagnosis of AD, as confirmed by a fasting serum TG >150 mg/dl coincide with an HDL-C of less than 50 mg/dl, were considered to be enrolled. Finally, and successive to a comprehensible concise for the expected benefits and side effects on top of the commitment to the entire protocol, eligible candidates settled for participation were provided with a written informed consent.
Enrollment:
- Therapeutic Lifestyle Changes (TLC) Run-in Period: Each and every eligible candidate was enrolled in a four-week TLC run-in (or lead-in) period to exclude responders and to obtain baseline data for non-responders prior to randomization.
- Randomization and Treatment Allocation: TLC non-responders with persistent AD were randomly allocated to one of the four treatment arms. In order to ensure a periodical balance among all study groups in the course of treatment allocation, permuted-block randomization with a block size of four was implemented and the system produced by this approach was adopted for the sequential random assignment of patients to treatment arms. .
Discontinuation of Treatment:
Although the absence of published consensus on drug discontinuation in the face of laboratory abnormalities has permitted a spectrum of indefinite decisions, mainly driven by clinical experience, clinical status and tolerability of the patient. For the present study discontinuation of treatment is considered if:
- Adverse events including flushing, nausea, vomiting, muscle pain, or dizziness turn sever enough to surpass patient's tolerability.
- Estimated glomerular filtration rate (eGFR) is reduced to ˂ 60ml/min per 1.73 m2 indicating renal insufficiency.
- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) increased to>3 Upper Limit of Normal (ULN) with the appearance of nausea, vomiting, fatigue, right upper quadrant pain or tenderness, fever, and/or rash.
- Serum uric acid exceeds the critical value of 6mg/dl.
Assessment of Treatments Responses:
Responses to the different treatments arms, in terms of efficacy and safety, are assessed by analyzing clinical and laboratory data collected at each visit over the entire course of the study, including a thorough medical history and previous medication records.
Statistical Analysis:
All statistical analyses were executed via the statistical package SPSS version 17.0 (SPSS, Inc.). Prior to analysis, Shapiro-Wilk test was used for assessing the normality of distributions for continuous variables, with the data expressed as the mean ± standard error (SE). Analysis of variance (ANOVA) was applied to compare the means of baseline characteristics among different treatments groups. Comprising the influence of the baseline level as a covariate, analysis of covariance (ANCOVA), embracing the least significant difference (LSD) for pair-wise comparison, was applied to assess treatment effects and safety profiles among different arms. Results were evaluated in terms of adjusted end line levels and percent changes from baseline levels. Multivariate Analysis of Covariance (MANCOVA), on the other hand, with further adjustments for relevant covariates was conducted whenever needed. Probability of less than 0.05 was considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Therapeutic Lifestyle Changes, Other: PlaceboNon-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks. |
| Fenofibrate Monotherapy | Active comparator | Other: Therapeutic Lifestyle Changes, Drug: FenofibrateNon-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks. |
| WMER Niacin Monotherapy | Active comparator | Other: Therapeutic Lifestyle Changes, Dietary Supplement: Wax Matrix Extended Release Niacin (WMER Niacin)Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks. |
| Combination Therapy | Active comparator | Other: Therapeutic Lifestyle Changes, Drug: Fenofibrate, Dietary Supplement: Wax Matrix Extended Release Niacin (WMER Niacin)Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI≥30 kg/m2.
- Conventional diagnosis of atherogenic dyslipidemia, confirmed by a fasting serum TG more than150 mg/dl coincide with an HDL-C of less than 50 mg/dl.
Key exclusion criteria (9 listed)
- The use of any antilipidemic medication.
- Findings suggestive for renal dysfunction (eGFR˂60ml/min per 1.73 m2).
- Findings suggestive for hepatic insufficiency (ALT and/or AST˃2ULN).
- Clinical or laboratory findings suggestive for thyroid dysfunction.
- Established diagnosis of Diabetes Mellitus.
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 |
|---|---|---|
| Therapeutic Lifestyle ChangesFour-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction. | Other | Combination Therapy, Fenofibrate Monotherapy, Placebo, WMER Niacin Monotherapy |
| Placebo | Other | Placebo |
| FenofibrateAlso: Lipanthyl | Drug | Combination Therapy, Fenofibrate Monotherapy |
| Wax Matrix Extended Release Niacin (WMER Niacin)Also: ENDUR-ACIN® | Dietary supplement | Combination Therapy, WMER Niacin Monotherapy |
Primary outcome
Changes Serum Triglyceride Levels
Time frame: Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments.
Assessments involve the measurement of serum Triglyceride (TG) level.
Changes in Serum Lipoprotein Cholesterol Levels
Time frame: Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments.
Assessments involve the measurement of serum Total (TC), High density lipoprotein (HDL-C) and direct Low density lipoprotein (d-LDL-C) cholesterol levels. Serum non HDL-C levels is calculated by subtracting HDL-C from TC. Serum Remnant cholesterol (RC) is calculated by subtracting HDL-C and d-LDL-C from TC.
Changes in Serum Apolipoprotein Levels
Time frame: Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments.
Assessments involve the measurement of serum Apolipoprotein A1 (Apo A1) and B (Apo B) levels.
6 secondary outcomes
Changes in Serum Fasting Glucose Levels.
Time frame: Changes from baseline were assessed at the end eighth week of treatments.
Changes in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Changes from baseline were assessed at the end of the eighth week of treatments.
Changes in Serum Uric Acid Levels
Time frame: Changes from baseline were assessed at the end of the eighth week of treatments.
Changes in Serum Enzymes Levels
Time frame: Changes from baseline were assessed at the end of the eighth week of treatments.
Changes in Systolic and Diastolic Blood Pressure
Time frame: Changes from baseline were assessed at the end of the eighth week of treatments.
Adverse Events
Time frame: Changes from baseline were assessed at the end of the eighth week of treatments.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (table, figures, and appendices).
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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.
Lewai S Abdulaziz, MSc PhD study chair
Al-Kindy college of Medicine, University of Baghdad
May S Al-Sabbagh, MSc study chair
College of Pharmacy, University of Baghdad
Marwah S Attar, MSc study director
College of Pharmacy, University of Baghdad
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Therapeutic Lifestyle Changes, Fenofibrate and Wax Matrix Extended Release Niacin (WMER Niacin) in people with Atherogenic Dyslipidemia and Obesity Associated Disorder, run by Lewai Sharki Abdulaziz, MSc PhD at 2 sites in Iraq.
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 9 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 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iraq. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes Serum Triglyceride Levels (time frame: Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments.). The study lists 3 primary outcomes in all. 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 24 Jan 2024.