Intermittent ClaudicationPhase 3NCT00071266
The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC
A Phase 3 study testing Niacin Extended Release and Lovastatin Tablets in people with Intermittent Claudication and Peripheral Vascular Disease, run by Kos Pharmaceuticals at 26 sites in United States.
Trial summary
The purpose of this study is to compare the dose response and safety of Niacin ER/Lovastatin, Niaspan® and Lovastatin with each other, in subjects with leg pain caused by a narrowing of their leg arteries. At least 870 subjects, with leg pain caused by a narrowing of their leg arteries will take part in this study. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Intermittent Claudication, Peripheral Vascular Disease
- What is being tested?
- Niacin Extended Release and Lovastatin Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 870 participants
- Where
- 26 sitesUnited States
- Study dates
- Oct 2003to not given
- Phase
- Phase 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men \& women at least 40 years of age or older. Women must not be pregnant nor breast-feeding \& not planning to become pregnant or to breast-feed.
- History of IC of the lower extremities which has been present for at least 6 months with no change in symptoms in the previous 3 months prior to screening.
- LDL-C of <160 mg/dL and Triglycerides <800.
Who cannot join
- Severe neuropathy.
- Gross obesity (BMI ≥ 40).
- Presence of critical limb ischemia defined as ischemic rest pain, gangrene, ulceration, or pending amputation of a lower extremity due to severe PAD.
- Surgical intervention to alleviate symptoms of claudication within 6 months or endovascular interventions within 3 months.
- Documented CAD taking any cholesterol-modifying agent and unable to undergo washout as judged by the Investigator or due to personal choice.
- Systolic blood pressure ≥160 mmHg \&/or diastolic blood pressure ≥95 mmHg.
- Presence of clinically significant laboratory test abnormalities for liver or renal function tests, thyroid function or HgbA1C.
- History of alcohol abuse or currently drinks alcohol in excess.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
HPV Heart P.A.
Columbia, Maryland, 21044
Clinical Cardiology Research Center
Dallas, Texas, 75246
University of Colorado Health Sciences Center
Denver, Colorado, 80200
University of Connecticut Health Center
Farmington, Connecticut, 06030
Penn State College of Medicine
Hershey, Pennsylvania, 17033
Baylor College of Medicine
Houston, Texas, 77030
River Cities Cardiology, MPC
Jeffersonville, Indiana, 47130
Hampton Roads Center for Clinical Research, Inc.
Norfolk, Virginia, 23502
COR Clinical Research
Oklahoma City, Oklahoma, 73104
VA Palo Alto Health Care System
Palo Alto, California, 94304
Radiant Research
Philadelphia, Pennsylvania, 19115
Tatum Ridge Internal Medicine
Phoenix, Arizona, 85032
St. Joseph Mercy-Oakland Research Office
Pontiac, Michigan, 48341
New Hope Research of Oregon
Portland, Oregon, 97219
University of California-Davis; Department of Surgery
Sacramento, California, 95819
Sacramento Heart & Vascular Medical Associates
Sacramento, California, 95825
Pro Research Group, LLC
San Antonio, Texas, 78205
Clinical Research Center of California
San Diego, California, 92103
Cardiovascular Center of Sarasota
Sarasota, Florida, 34239
Scottsdale Cardiovascular Research Institute, LLC
Scottsdale, Arizona, 85251
Saint Louis University
St Louis, Missouri, 63104
Carolina Pharmaceutical Research
Statesville, North Carolina, 28625
North County Internal Medicine
Vista, California, 92083
Clinical Research Center of Georgia
Warner Robins, Georgia, 31093
Care Foundation, Inc
Wausau, Wisconsin, 54401
Mainline Health Heart Center
Wynnewood, Pennsylvania, 19096
About this study
Official title: The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - a Matrix Design
The purpose of this study is to compare the dose response and safety of Niacin ER/Lovastatin, Niaspan® and Lovastatin with each other, in subjects with leg pain caused by a narrowing of their leg arteries.
At least 870 subjects, with leg pain caused by a narrowing of their leg arteries will take part in this study.
Both Niaspan and lovastatin (Mevacor®) are approved by the United States Food and Drug Administration (FDA) to treat high cholesterol. Niacin ER/Lovastatin (Advicor®), a combination of these two drugs, is also approved by the FDA to treat high cholesterol. The use of Niacin ER/Lovastatin to treat narrowing of leg arteries and relieve "intermittent claudication" (leg pain caused by narrowing of the arteries in the leg) is considered investigational. An investigational use is one that is not approved by the FDA.
Read the detailed description
This is a Phase 3, 32-week, double-blind, diet-intervention, randomized, parallel group, ten-arm, multi-center, multi-national, dose titration study evaluating the safety and efficacy of NL in patients with intermittent claudication (IC).
The objectives of this study are to evaluate the safety and efficacy of NL in patients with IC. The primary efficacy analysis will be the percent change from baseline in Peak Walking Time (PWT) calculated from the natural logarithm of the ratio of the time walked on treadmill at the Week 32 Visit divided by the time walked at baseline. Other efficacy measures will include Claudication Onset Time (COT) percent changes from baseline to Week 32 , changes in Ankle Brachial Index (ABI), Quality of Life (QoL) percent changes at Weeks 20 and 32, lower limb amputations, composite of cardiovascular events (MI, stroke, and vascular death), and coronary and peripheral artery revascularizations. Safety variables will include serum transaminases, routine chemistry parameters, hematology, and adverse events. Pharmacokinetic analyses will be conducted as well.
- Being tested
- Niacin Extended Release and Lovastatin Tablets
- Keywords
- Intermittent Claudication, Peripheral Arterial Disease, Atherosclerosis, Niacin, Lovastatin, PAD, IC
- Medical subject headings
- Intermittent Claudication, Peripheral Vascular Diseases, Peripheral Arterial Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niacin Extended Release and Lovastatin TabletsDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2003 (estimated)
- Study startOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ClaudicationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 870 participants
Sponsor and investigators
- Lead sponsor
- Kos Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071266
- Sponsor's protocol ID
- MA-03-010401
- Other IDs
- The TROPIC Study
- Status last verified
- Oct 2006
- First submitted
- 16 Oct 2003
- Last updated
- 2 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - a Matrix Design
- ClinicalTrials.gov ID
- NCT00071266
- Acronym / sponsor ID
- MA-03-010401
- Keywords
- Intermittent Claudication, Peripheral Arterial Disease, Atherosclerosis, Niacin, Lovastatin, PAD, IC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 870 participants
- Lead sponsor
- Kos PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- First posted
- 20 Oct 2003 (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 purpose of this study is to compare the dose response and safety of Niacin ER/Lovastatin, Niaspan® and Lovastatin with each other, in subjects with leg pain caused by a narrowing of their leg arteries.
At least 870 subjects, with leg pain caused by a narrowing of their leg arteries will take part in this study.
Both Niaspan and lovastatin (Mevacor®) are approved by the United States Food and Drug Administration (FDA) to treat high cholesterol. Niacin ER/Lovastatin (Advicor®), a combination of these two drugs, is also approved by the FDA to treat high cholesterol. The use of Niacin ER/Lovastatin to treat narrowing of leg arteries and relieve "intermittent claudication" (leg pain caused by narrowing of the arteries in the leg) is considered investigational. An investigational use is one that is not approved by the FDA.
Detailed description
This is a Phase 3, 32-week, double-blind, diet-intervention, randomized, parallel group, ten-arm, multi-center, multi-national, dose titration study evaluating the safety and efficacy of NL in patients with intermittent claudication (IC).
The objectives of this study are to evaluate the safety and efficacy of NL in patients with IC. The primary efficacy analysis will be the percent change from baseline in Peak Walking Time (PWT) calculated from the natural logarithm of the ratio of the time walked on treadmill at the Week 32 Visit divided by the time walked at baseline. Other efficacy measures will include Claudication Onset Time (COT) percent changes from baseline to Week 32 , changes in Ankle Brachial Index (ABI), Quality of Life (QoL) percent changes at Weeks 20 and 32, lower limb amputations, composite of cardiovascular events (MI, stroke, and vascular death), and coronary and peripheral artery revascularizations. Safety variables will include serum transaminases, routine chemistry parameters, hematology, and adverse events. Pharmacokinetic analyses will be conducted as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men \& women at least 40 years of age or older. Women must not be pregnant nor breast-feeding \& not planning to become pregnant or to breast-feed.
- History of IC of the lower extremities which has been present for at least 6 months with no change in symptoms in the previous 3 months prior to screening.
- LDL-C of <160 mg/dL and Triglycerides <800.
Key exclusion criteria (8 listed)
- Severe neuropathy.
- Gross obesity (BMI ≥ 40).
- Presence of critical limb ischemia defined as ischemic rest pain, gangrene, ulceration, or pending amputation of a lower extremity due to severe PAD.
- Surgical intervention to alleviate symptoms of claudication within 6 months or endovascular interventions within 3 months.
- Documented CAD taking any cholesterol-modifying agent and unable to undergo washout as judged by the Investigator or due to personal choice.
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 |
|---|---|---|
| Niacin Extended Release and Lovastatin Tablets | Drug | – |
Primary outcome
Not reported in the source record.
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 2 Nov 2006.
Related trials for Intermittent Claudication
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
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.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Niacin Extended Release and Lovastatin Tablets in people with Intermittent Claudication and Peripheral Vascular Disease, run by Kos Pharmaceuticals at 26 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 3 inclusion and 8 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 2 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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.
What does this phase mean?
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.
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 2 Nov 2006.