HypercholesterolemiaNCT01894230
Genetically Guided Statin Therapy
A study testing SLCO1B1*5 allele testing, results reported at randomization, SLCO1B1*5 allele testing, results reported at end of study and Genetic testing for SLCO1B1*5 allele in people with Hypercholesterolemia and Hydroxy-methylglutaryl-coenzyme A (HMG Co-A) Reductase Inhibitors Adverse Reaction, run by Duke University at 2 sites in United States.
Trial summary
The purpose of this study is to examine if using genetics can improve statin adherence in patients who should be taking statins but are not because of prior side effects. This study will assist physicians/providers in making a personalized health care plan for prevention of cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia, Hydroxy-methylglutaryl-coenzyme A (HMG Co-A) Reductase Inhibitors Adverse Reaction
- What is being tested?
- SLCO1B1*5 allele testing, results reported at randomization, SLCO1B1*5 allele testing, results reported at end of study and Genetic testing for SLCO1B1*5 allele
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to 30 Apr 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current patient (defined as seen in the last year) of the Duke Primary Care at Pickett Road, Pickens Family Medicine Center or Travis Air Force Base
- Age greater than or equal to 18 years
- Current non-utilization of statin therapy for either of the following reasons: (a) Prior side effects thought to be attributed by the patient to statin use AND/OR (b) Physician removal of statin due to presumed associated side effects
- No statin use for the past 6 weeks
- Active email account
- Computer access available in order to complete on-line surveys
- Ability to provide informed consent
Who cannot join
- Prior rhabdomyolysis, or Creatine Kinase (CK) elevation > 10 times the upper limit of normal with any statin therapy
- Prior unexplained elevation in hepatic enzymes [Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 3 times upper limit of normal] with any statin therapy
- Current daily grapefruit juice usage (on average >1quart/day)
- Expected long term use (longer than 3 months) of the following medications known to interfere with statin metabolism or disposition at time of enrollment until the randomization is complete. However, short-term (<14 days) is allowed for the duration of the study
- Participation in a drug research study in the past 30 days
- Previous use of 4 or more statins
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University
Durham, North Carolina, 27710
David Grant US Air Force Medical Center
Travis Air Force Base, California, 94535
About this study
Official title: Genetically Guided Statin Therapy to Improve Medication Adherence
The purpose of this study is to examine if using genetics can improve statin adherence in patients who should be taking statins but are not because of prior side effects. This study will assist physicians/providers in making a personalized health care plan for prevention of cardiovascular disease.
Read the detailed description
Hydroxy-methylglutaryl-coenzyme A (HMG Co-A) reductase inhibitors ("statins") are commonly prescribed to lower low density lipoprotein cholesterol (LDLc) and to prevent cardiovascular disease (CVD), a leading cause of morbidity and mortality. Long-term adherence to statins in the primary care environment is challenging; consequences of statin non-adherence include higher LDLc levels, hospitalizations, costs, and death due to CVD.
Medication non-adherence is complex and multifactorial and can be associated with a number of factors including medication cost, complexity of medication regimen, poor provider-patient relationship / communication, and adverse side effects. For statins, side effects such as muscle aches, cramping, and pain (referred to broadly as statin-related myopathy) are a frequent cause of non-adherence. These symptoms are non-specific and are frequent reasons for stopping statin therapy, due to patient or provider concern about the possibility of statin-related myopathy. Many patients may be needlessly deprived of the cardiovascular benefits of long-term statin use.
A genetic risk factor for statin myopathy and subsequent non-adherence has recently been identified. In a genome-wide association study, a genetic variant (named SLCO1B1*5) was a main contributor of statin myopathy. It was demonstrated that the SLCO1B1*5 variant is not only a predictor of myopathy, but also of premature statin discontinuation. The risk with the *5 allele is statin specific: greatest with simvastatin and atorvastatin use, the least with pravastatin or rosuvastatin. Therefore, the SLCO1B1*5 variant is common, can predict myopathy, subsequent non-adherence, and due to its statin-specific effects creates a novel research paradigm for personalizing statins to an individual's genetic profile. Carriers of the SLCO1B1*5 variant may do best on rosuvastatin, pravastatin, or fluvastatin whereas non-carriers may be treated with any statin.
The objective of this study is to conduct a randomized trial comparing two strategies:
- genetically guided statin therapy vs.
- usual care (i.e., a strategy without genetics) on the effects of statin adherence and LDLc lowering.
The overall hypothesis is that genetically guided statin therapy will lead to greater statin adherence and lower LDLc when compared to a non-guided strategy. The design of this trial will randomize primary care patients within Duke University Health System (DUHS) and travis Air Force Base (TAFB) clinics that are nonadherent to statins due to prior side-effects in an unblinded, 1:1 fashion, stratified by SLCO1B1*5 genotype.
- Conditions
- Hypercholesterolemia, Hydroxy-methylglutaryl-coenzyme A (HMG Co-A) Reductase Inhibitors Adverse Reaction
- Being tested
- SLCO1B1*5 allele testing, results reported at randomization, SLCO1B1*5 allele testing, results reported at end of study, Genetic testing for SLCO1B1*5 allele
- Keywords
- high cholesterol, genetic testing, medication adherence, statins, Adverse Effects, pharmacogenetics
- Medical subject headings
- Hypercholesterolemia, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLCO1B1*5 allele testing, results reported at randomizationGenetic
Also called genotype informed statin therapy (GIST)
Genetic testing for SLCO1B1*5 allele and reporting of results to patient and provider at randomization
SLCO1B1*5 allele testing, results reported at end of studyGenetic
Genetic testing for SLCO1B1*5 allele and reporting of results to patient and provider at end of study
Genetic testing for SLCO1B1*5 alleleGenetic
Blood test for SLCO1B1*5 allele
| Study group | Role | What they receive |
|---|---|---|
| Genotype results plus usual care | Experimental | SLCO1B1*5 allele testing, results reported at randomization: genetic testing for SLCO1B1*5 allele and reporting of results to patient and provider at randomization. Receives: Genetic: SLCO1B1*5 allele testing, results reported at randomization; Genetic: Genetic testing for SLCO1B1*5 allele |
| Usual care only | Active comparator | SLCO1B1*5 allele testing, results reported at end of study: genetic testing for SLCO1B1*5 allele and reporting of results to patient and provider at end of study Receives: Genetic: SLCO1B1*5 allele testing, results reported at end of study; Genetic: Genetic testing for SLCO1B1*5 allele |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morisky Medication Adherence Scale (MMAS) Score
The Morisky Medication Adherence Scale (MMAS) is a self-reported measure of adherence, collected at baseline for general medication and at 3 and 8 months of followup for statin specific adherence. The eight-item MMAS survey will be used. This is a modified version of the original four-item MMAS capturing further aspects of adherence behavior. The survey includes 8 yes/no items that are summed to create an overall adherence score ranging from of 0 to 8, with higher scores indicating better adherence. The primary hypothesis is that the genetically guided statin therapy leads to greater adherence of statin therapy, corresponding to a higher MMAS score.
Measured: 3 months and 8 months
Secondary outcomes (9)
Low Density Lipoprotein Cholesterol (LDLc) at Baseline, Month 3 and Month 8
The continuous outcomes LDLc will be modeled as a linear regression with arm and baseline LDL as predictors.
Measured: Baseline, Month 3, Month 8
Medication Possession Ratio (MPR) From Baseline to Last Patient Follow-up
Medication possession ratio will be calculated based on number of statin medication refills over time from randomization to end of follow up. MPR is calculated as follows: 1.Sum of the days' supply of all statin medications is the sum of the number of pills dispensed for each statin prescription during follow up (taken from 3-month, 4-month and 8-month statin utilization review) 2.Sum of the days of follow up = date of 8-month follow up survey - date of randomization 3.MPR = #1/#2 MPR will be modeled as a linear regression with arm, genotype, and site as predictors.
Measured: Baseline to Last patient follow-up in study (3 months or 8 months)
Number of Participants Reporting New Statin Prescriptions
The number of new prescriptions is binary and will be modeled with logistic regression with arm, genotype, and site as predictors. Any variables imbalanced between arms will also be included as covariates.
Measured: Baseline, Month 3, Month 8
Brief Pain Inventory (BPI) Score - Pain Severity at Month 3 and Month 8
Brief Pain Inventory data will be taken from 3 and 8-month follow up Patient Surveys. Pain severity and pain interference will be compared between groups. Both of these measures will be modeled as a linear regression with arm, genotype, and site as predictors. Transformations of the response may be explored depending on the distribution of the regression residuals. Baseline pain scores will also be included as a covariate to account for baseline variability.
Scores range from 0-10. Higher scores indicate higher pain severity.
Measured: Month 3 and Month 8
Brief Pain Inventory (BPI) Score - Pain Interference at Month 3 and Month 8
Brief Pain Inventory data will be taken from 3 and 8-month follow up Patient Surveys. -Pain severity and pain interference will be compared between groups -Both of these measures will be modeled as a linear regression with arm as predictor. Baseline pain scores will also be included as a covariate to account for baseline variability.
Scores range from 0-10. Higher scores indicate higher pain interference with daily activities.
Measured: Month 3 and Month 8
Change in Short Form -12 Item (SF-12) Health Survey - Physical Component (PC)
Month 3 and Month 8 SF12 scores for mental and physical health will be compared. Both of these measures will be modeled as a linear regression with arm as predictor. Baseline SF-12 scores will also be included as a covariate to account for baseline variability.
Ranges from 0 to 100, where a zero score indicates the lowest level of physical health measured by the scales and 100 indicates the highest level of physical health
Measured: Baseline, Month 3, Month 8
Change in Short Form -12 Item (SF-12) Health Survey - Mental Component (MC)
Month 3 and Month 8 SF12 scores for mental and physical health will be compared. Both of these measures will be modeled as a linear regression with arm as predictor. Baseline SF-12 scores will also be included as a covariate to account for baseline variability.
Ranges from 0 to 100, where a zero score indicates the lowest level of mental health measured by the scales and 100 indicates the highest level of mental health.
Measured: Baseline, Month 3, Month 8
Physical Activity Scale Score
Activity levels will be compared at the end of 8-months. Activity levels are defined by a five-level ordinal variable (0-4; higher level corresponding to higher activity). which was calculated based on survey answers. An ordinal logistic regression model will be used with arm as predictor. The assumption of proportional odds will be checked, and if it is not met, a multinomial regression model will be used. -Baseline physical activity will also be included as a covariate to account for baseline variability.
Scale score (0-4): 0 - Inactivity, 1 - Ligh-intensity activity, 2 - moderate-intensity activity, 3 - Hard-intensity activity, 5 - very hard-intensity activity
Measured: Baseline and Month 8
Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8
- Questionnaire administered at baseline, 3 months, and 8 months
- This instrument assesses beliefs regarding necessity and concerns related to disease-specific medications
- The score ranges from 5 to 25 representing the sum of 5 questions. This will be modeled with linear regression including treatment as predictor. Baseline BMQ scores will also be included as a covariate to account for baseline variability.
Higher score corresponds to higher thought necessity and higher thought concerns about taking the medication. The higher the necessity score, the more the patient believed statins necessary for their health. The higher the concerns score, the more the patient was concerned about taking stains (side effects).
Measured: Baseline, Month 3, Month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJul 2013
- Primary completion30 Apr 2016
- Study completion30 Apr 2016
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- David Grant U.S. Air Force Medical Center
- Responsible party
- Sponsor
- Investigators
- Deepak Voora, MD, Principal investigator, Duke UniversityHenry Lau, MD, Principal investigator, David Grant US Air Force Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894230
- Sponsor's protocol ID
- Pro00044989
- Other IDs
- Pro00045542
- Status last verified
- Jun 2017
- First submitted
- 3 Jul 2013
- Last updated
- 23 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Peyser B, Perry EP, Singh K, Gill RD, Mehan MR, Haga SB, Musty MD, Milazzo NA, Savard D, Li YJ, Trujilio G, Voora D. Effects of Delivering SLCO1B1 Pharmacogenetic Information in Randomized Trial and Observational Settings. Circ Genom Precis Med. 2018 Sep;11(9):e002228. doi: 10.1161/CIRCGEN.118.002228.
PubMed 30354330Ramsey LB, Johnson SG, Caudle KE, Haidar CE, Voora D, Wilke RA, Maxwell WD, McLeod HL, Krauss RM, Roden DM, Feng Q, Cooper-DeHoff RM, Gong L, Klein TE, Wadelius M, Niemi M. The clinical pharmacogenetics implementation consortium guideline for SLCO1B1 and simvastatin-induced myopathy: 2014 update. Clin Pharmacol Ther. 2014 Oct;96(4):423-8. doi: 10.1038/clpt.2014.125. Epub 2014 Jun 11.
PubMed 24918167
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetically Guided Statin Therapy to Improve Medication Adherence
- ClinicalTrials.gov ID
- NCT01894230
- Acronym / sponsor ID
- Pro00044989
- Conditions
- Hypercholesterolemia, Hydroxy-methylglutaryl-coenzyme A (HMG Co-A) Reductase Inhibitors Adverse Reaction
- Keywords
- high cholesterol, genetic testing, medication adherence, statins, Adverse Effects, pharmacogenetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- David Grant U.S. Air Force Medical Center
- Study start
- Jul 2013
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Posted 23 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine if using genetics can improve statin adherence in patients who should be taking statins but are not because of prior side effects. This study will assist physicians/providers in making a personalized health care plan for prevention of cardiovascular disease.
Detailed description
Hydroxy-methylglutaryl-coenzyme A (HMG Co-A) reductase inhibitors ("statins") are commonly prescribed to lower low density lipoprotein cholesterol (LDLc) and to prevent cardiovascular disease (CVD), a leading cause of morbidity and mortality. Long-term adherence to statins in the primary care environment is challenging; consequences of statin non-adherence include higher LDLc levels, hospitalizations, costs, and death due to CVD.
Medication non-adherence is complex and multifactorial and can be associated with a number of factors including medication cost, complexity of medication regimen, poor provider-patient relationship / communication, and adverse side effects. For statins, side effects such as muscle aches, cramping, and pain (referred to broadly as statin-related myopathy) are a frequent cause of non-adherence. These symptoms are non-specific and are frequent reasons for stopping statin therapy, due to patient or provider concern about the possibility of statin-related myopathy. Many patients may be needlessly deprived of the cardiovascular benefits of long-term statin use.
A genetic risk factor for statin myopathy and subsequent non-adherence has recently been identified. In a genome-wide association study, a genetic variant (named SLCO1B1*5) was a main contributor of statin myopathy. It was demonstrated that the SLCO1B1*5 variant is not only a predictor of myopathy, but also of premature statin discontinuation. The risk with the *5 allele is statin specific: greatest with simvastatin and atorvastatin use, the least with pravastatin or rosuvastatin. Therefore, the SLCO1B1*5 variant is common, can predict myopathy, subsequent non-adherence, and due to its statin-specific effects creates a novel research paradigm for personalizing statins to an individual's genetic profile. Carriers of the SLCO1B1*5 variant may do best on rosuvastatin, pravastatin, or fluvastatin whereas non-carriers may be treated with any statin.
The objective of this study is to conduct a randomized trial comparing two strategies:
- genetically guided statin therapy vs.
- usual care (i.e., a strategy without genetics) on the effects of statin adherence and LDLc lowering.
The overall hypothesis is that genetically guided statin therapy will lead to greater statin adherence and lower LDLc when compared to a non-guided strategy. The design of this trial will randomize primary care patients within Duke University Health System (DUHS) and travis Air Force Base (TAFB) clinics that are nonadherent to statins due to prior side-effects in an unblinded, 1:1 fashion, stratified by SLCO1B1*5 genotype.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genotype results plus usual care | Experimental | Genetic: SLCO1B1*5 allele testing, results reported at randomization, Genetic: Genetic testing for SLCO1B1*5 alleleSLCO1B1*5 allele testing, results reported at randomization: genetic testing for SLCO1B1*5 allele and reporting of results to patient and provider at randomization. |
| Usual care only | Active comparator | Genetic: SLCO1B1*5 allele testing, results reported at end of study, Genetic: Genetic testing for SLCO1B1*5 alleleSLCO1B1*5 allele testing, results reported at end of study: genetic testing for SLCO1B1*5 allele and reporting of results to patient and provider at end of study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Current patient (defined as seen in the last year) of the Duke Primary Care at Pickett Road, Pickens Family Medicine Center or Travis Air Force Base
- Age greater than or equal to 18 years
- Current non-utilization of statin therapy for either of the following reasons: (a) Prior side effects thought to be attributed by the patient to statin use AND/OR (b) Physician removal of statin due to presumed associated side effects
- No statin use for the past 6 weeks
- Active email account
Key exclusion criteria (6 listed)
- Prior rhabdomyolysis, or Creatine Kinase (CK) elevation > 10 times the upper limit of normal with any statin therapy
- Prior unexplained elevation in hepatic enzymes [Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 3 times upper limit of normal] with any statin therapy
- Current daily grapefruit juice usage (on average >1quart/day)
- Expected long term use (longer than 3 months) of the following medications known to interfere with statin metabolism or disposition at time of enrollment until the randomization is complete. However, short-term (<14 days) is allowed for the duration of the study
- Participation in a drug research study in the past 30 days
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 |
|---|---|---|
| SLCO1B1*5 allele testing, results reported at randomizationAlso: genotype informed statin therapy (GIST)Genetic testing for SLCO1B1*5 allele and reporting of results to patient and provider at randomization | Genetic | Genotype results plus usual care |
| SLCO1B1*5 allele testing, results reported at end of studyGenetic testing for SLCO1B1*5 allele and reporting of results to patient and provider at end of study | Genetic | Usual care only |
| Genetic testing for SLCO1B1*5 alleleBlood test for SLCO1B1*5 allele | Genetic | Genotype results plus usual care, Usual care only |
Primary outcome
Morisky Medication Adherence Scale (MMAS) Score
Time frame: 3 months and 8 months
The Morisky Medication Adherence Scale (MMAS) is a self-reported measure of adherence, collected at baseline for general medication and at 3 and 8 months of followup for statin specific adherence. The eight-item MMAS survey will be used. This is a modified version of the original four-item MMAS capturing further aspects of adherence behavior. The survey includes 8 yes/no items that are summed to create an overall adherence score ranging from of 0 to 8, with higher scores indicating better adherence. The primary hypothesis is that the genetically guided statin therapy leads to greater adherence of statin therapy, corresponding to a higher MMAS score.
9 secondary outcomes
Low Density Lipoprotein Cholesterol (LDLc) at Baseline, Month 3 and Month 8
Time frame: Baseline, Month 3, Month 8
Medication Possession Ratio (MPR) From Baseline to Last Patient Follow-up
Time frame: Baseline to Last patient follow-up in study (3 months or 8 months)
Number of Participants Reporting New Statin Prescriptions
Time frame: Baseline, Month 3, Month 8
Brief Pain Inventory (BPI) Score - Pain Severity at Month 3 and Month 8
Time frame: Month 3 and Month 8
Brief Pain Inventory (BPI) Score - Pain Interference at Month 3 and Month 8
Time frame: Month 3 and Month 8
Change in Short Form -12 Item (SF-12) Health Survey - Physical Component (PC)
Time frame: Baseline, Month 3, Month 8
Change in Short Form -12 Item (SF-12) Health Survey - Mental Component (MC)
Time frame: Baseline, Month 3, Month 8
Physical Activity Scale Score
Time frame: Baseline and Month 8
Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8
Time frame: Baseline, Month 3, Month 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30354330Peyser B, Perry EP, Singh K, Gill RD, Mehan MR, Haga SB, Musty MD, Milazzo NA, Savard D, Li YJ, Trujilio G, Voora D. Effects of Delivering SLCO1B1 Pharmacogenetic Information in Randomized Trial and Observational Settings. Circ Genom Precis Med. 2018 Sep;11(9):e002228. doi: 10.1161/CIRCGEN.118.002228.
- Derived from this study: PubMed 24918167Ramsey LB, Johnson SG, Caudle KE, Haidar CE, Voora D, Wilke RA, Maxwell WD, McLeod HL, Krauss RM, Roden DM, Feng Q, Cooper-DeHoff RM, Gong L, Klein TE, Wadelius M, Niemi M. The clinical pharmacogenetics implementation consortium guideline for SLCO1B1 and simvastatin-induced myopathy: 2014 update. Clin Pharmacol Ther. 2014 Oct;96(4):423-8. doi: 10.1038/clpt.2014.125. Epub 2014 Jun 11.
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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.
Deepak Voora, MD principal investigator
Duke University
Henry Lau, MD principal investigator
David Grant US Air Force Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLCO1B1*5 allele testing, results reported at randomization, SLCO1B1*5 allele testing, results reported at end of study and Genetic testing for SLCO1B1*5 allele in people with Hypercholesterolemia and Hydroxy-methylglutaryl-coenzyme A (HMG Co-A) Reductase Inhibitors Adverse Reaction, run by Duke University at 2 sites in United States.
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 7 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 23 Jun 2017. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2017). 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?
Morisky Medication Adherence Scale (MMAS) Score (time frame: 3 months and 8 months). 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 NCT01894230, which also lists 2 linked publications.
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 Jun 2017.