DyslipidemiaPhase 4NCT00194402
SLIM: Combined Effects of Slo-Niacin and Atorvastatin on Lipoproteins and Inflammatory Markers in Hyperlipidemia
A Phase 4 study testing Slo-Niacin, atorvastatin in people with Dyslipidemia, run by University of Washington at 1 site in United States.
Trial summary
Slo-Niacin and atorvastatin (Lipitor) are both drugs that lower cholesterol. In this research, we will compare the effectiveness of Slo-Niacin and atorvastatin taken alone and together. This study will help show how the individual benefits of the two drugs taken separately can be combined when taken together. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Slo-Niacin, atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Jan 2006
- Phase
- Phase 4
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LDL-C > 130 mg/dL
- HDL-C <= 45 mg/dL in men and <= 55 mg/dL in women
Who cannot join
- history of hypersensitivity to any statin, niacin or aspirin
- diagnosis of diabetes or a fasting glucose > 125 mg/dL
- hyper or hypothyroidism (unless treatment stable)
- meet other health, medication, and logistical criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwest Lipid Research Clinic, University of Washington
Seattle, Washington, 98104
About this study
Official title: SLIM: Combined Effects of Slo-Niacin and Atorvastatin on Lipoproteins and Inflammatory Markers
Slo-Niacin and atorvastatin (Lipitor) are both drugs that lower cholesterol. In this research, we will compare the effectiveness of Slo-Niacin and atorvastatin taken alone and together. This study will help show how the individual benefits of the two drugs taken separately can be combined when taken together.
Read the detailed description
Combined niacin and a statin treatment has greater potential value than either agent alone for the dyslipidemia of insulin resistance, obesity and the metabolic syndrome. The efficacy of Slo-Niacin and atorvastatin has not been formally examined in this setting.
Methods: Forty-four dyslipidemic men and women (LDL-C >130mg/dL and below average HDL-C (<55 in women and <45 in men) were randomized to a 3 month course of atorvastatin 10 mg or Slo-Niacin increased monthly at doses of 500, 1000 and 1500 mg/day. The alternate drug was added in the second 3-month segment. Lipid profiles and transaminase measurements were obtained monthly and full lipoprotein quantifications, apoproteins, remnant like lipoproteins (RLP), LDL buoyancy, glucose, insulin, and C-reactive protein were measured at the end of each 3-month sequence. Results: Mean entry lipids were (mg/dL) TG 187, LDL-C 171, HDL-C 39. Mean BMI was 32.6 Kg/M2. When Slo-Niacin and atorvastatin were given alone, respective decreases in triglyceride (TG) were 18% and 10%, LDL-C 12% and 36% and non-HDL-C 15% and 36%. HDL-C increased 8% and 6%, respectively. Combined therapy decreased median TG 33% and mean LDL-C 43% and increased mean HDL-C 10%. Mean hs CRP decreased 23% and RLP 44.5% in the combined groups. Conclusions: Slo-Niacin with atorvastatin improves all lipoprotein fractions, RLP and hsCRP in combined hyperlipidemia. The reduction of LDL with the drug combination is equivalent to that obtained with 20-80 mg of atorvastatin alone.
- Conditions
- Dyslipidemia
- Being tested
- Slo-Niacin, atorvastatin
- Keywords
- cholesterol, dyslipidemia, hypercholesterolemia, C-reactive protein
- Medical subject headings
- Dyslipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slo-Niacin, atorvastatinDrug
Also called Lipitor (R) (Atorvastatin), Slo-Niacin (R) (time-release niacin
Atorvastatin 10 mg qd for 12 or 24 weeks. Time-released niacin 1500 mg qd (titrated from 500mg to 1000mg and then to 1500 mg at 4 week intervals) taken for 12 or 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Atorvastatin 10 mg for 12 weeks followed by Slo-Niacin (titrated from 500 to 1500 mg over 8 weeks) taken with atorvastatin 10 mg for an additional 12 weeks Receives: Drug: Slo-Niacin, atorvastatin |
| 2 | Active comparator | Slo-Niacin (titrated from 500 to 1500 mg over 8 weeks) for 12 weeks followed by atorvastatin 10 mg taken with Slo-Niacin 1500 mg for an additional 12 weeks Receives: Drug: Slo-Niacin, atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C change for atorvastatin 10 mg, Slo-Niacin 1500 mg, and the two together.
Measured: Change from baseline to 12 weeks and end of intervention
Secondary outcomes (1)
Change in HDL-C, HDL2-C, HDL3-C, LDL-C:HDL-C, triglyceride, remnant lipoprotein, apoproteins A-I and B, LDL buoyancy, hsCRP, glucose, insulin, and SGOT.
Measured: Change from baseline to end of 12 weeks and/or end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startAug 2003
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Upsher-Smith Laboratories
- Investigators
- Robert H. Knopp, MD, Principal investigator, Northwest Lipid Research Clinic, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194402
- Sponsor's protocol ID
- 03-6262-A
- Status last verified
- Aug 2008
- First submitted
- 12 Sep 2005
- Last updated
- 21 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SLIM: Combined Effects of Slo-Niacin and Atorvastatin on Lipoproteins and Inflammatory Markers
- ClinicalTrials.gov ID
- NCT00194402
- Acronym / sponsor ID
- 03-6262-A
- Conditions
- Dyslipidemia
- Keywords
- cholesterol, dyslipidemia, hypercholesterolemia, C-reactive protein
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Upsher-Smith Laboratories
- Study start
- Aug 2003
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 19 Sep 2005 (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.
Slo-Niacin and atorvastatin (Lipitor) are both drugs that lower cholesterol. In this research, we will compare the effectiveness of Slo-Niacin and atorvastatin taken alone and together. This study will help show how the individual benefits of the two drugs taken separately can be combined when taken together.
Detailed description
Combined niacin and a statin treatment has greater potential value than either agent alone for the dyslipidemia of insulin resistance, obesity and the metabolic syndrome. The efficacy of Slo-Niacin and atorvastatin has not been formally examined in this setting.
Methods: Forty-four dyslipidemic men and women (LDL-C >130mg/dL and below average HDL-C (<55 in women and <45 in men) were randomized to a 3 month course of atorvastatin 10 mg or Slo-Niacin increased monthly at doses of 500, 1000 and 1500 mg/day. The alternate drug was added in the second 3-month segment. Lipid profiles and transaminase measurements were obtained monthly and full lipoprotein quantifications, apoproteins, remnant like lipoproteins (RLP), LDL buoyancy, glucose, insulin, and C-reactive protein were measured at the end of each 3-month sequence. Results: Mean entry lipids were (mg/dL) TG 187, LDL-C 171, HDL-C 39. Mean BMI was 32.6 Kg/M2. When Slo-Niacin and atorvastatin were given alone, respective decreases in triglyceride (TG) were 18% and 10%, LDL-C 12% and 36% and non-HDL-C 15% and 36%. HDL-C increased 8% and 6%, respectively. Combined therapy decreased median TG 33% and mean LDL-C 43% and increased mean HDL-C 10%. Mean hs CRP decreased 23% and RLP 44.5% in the combined groups. Conclusions: Slo-Niacin with atorvastatin improves all lipoprotein fractions, RLP and hsCRP in combined hyperlipidemia. The reduction of LDL with the drug combination is equivalent to that obtained with 20-80 mg of atorvastatin alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Slo-Niacin, atorvastatinAtorvastatin 10 mg for 12 weeks followed by Slo-Niacin (titrated from 500 to 1500 mg over 8 weeks) taken with atorvastatin 10 mg for an additional 12 weeks |
| 2 | Active comparator | Drug: Slo-Niacin, atorvastatinSlo-Niacin (titrated from 500 to 1500 mg over 8 weeks) for 12 weeks followed by atorvastatin 10 mg taken with Slo-Niacin 1500 mg for an additional 12 weeks |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- LDL-C > 130 mg/dL
- HDL-C <= 45 mg/dL in men and <= 55 mg/dL in women
Key exclusion criteria (4 listed)
- history of hypersensitivity to any statin, niacin or aspirin
- diagnosis of diabetes or a fasting glucose > 125 mg/dL
- hyper or hypothyroidism (unless treatment stable)
- meet other health, medication, and logistical criteria
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 |
|---|---|---|
| Slo-Niacin, atorvastatinAlso: Lipitor (R) (Atorvastatin), Slo-Niacin (R) (time-release niacinAtorvastatin 10 mg qd for 12 or 24 weeks. Time-released niacin 1500 mg qd (titrated from 500mg to 1000mg and then to 1500 mg at 4 week intervals) taken for 12 or 24 weeks. | Drug | 1, 2 |
Primary outcome
LDL-C change for atorvastatin 10 mg, Slo-Niacin 1500 mg, and the two together.
Time frame: Change from baseline to 12 weeks and end of intervention
1 secondary outcome
Change in HDL-C, HDL2-C, HDL3-C, LDL-C:HDL-C, triglyceride, remnant lipoprotein, apoproteins A-I and B, LDL buoyancy, hsCRP, glucose, insulin, and SGOT.
Time frame: Change from baseline to end of 12 weeks and/or end of intervention
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 21 Aug 2008.
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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.
Robert H. Knopp, MD principal investigator
Northwest Lipid Research Clinic, University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Slo-Niacin, atorvastatin in people with Dyslipidemia, run by University of Washington at 1 site 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 2 inclusion and 4 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 21 Aug 2008. 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 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.
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?
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?
LDL-C change for atorvastatin 10 mg, Slo-Niacin 1500 mg, and the two together. (time frame: Change from baseline to 12 weeks and end of intervention). 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 21 Aug 2008.