Coronary Artery DiseasePhase 4NCT00832572
Study of Ranexa in Patients With Coronary Artery Disease and Painful Polyneuropathy
A Phase 4 study testing Ranolazine in people with Coronary Artery Disease and Pain, run by Gilead Sciences at 1 site in United States.
Trial summary
This study was to determine whether ranolazine was effective in the treatment of neuropathic pain in patients with coronary artery disease. Eligibility required neurological examination by the study doctor and assessment of the patient's pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Pain, Peripheral Nervous System Diseases
- What is being tested?
- Ranolazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jun 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged ≥ 18 years
- Coronary artery disease with a clinically diagnosed peripheral neuropathy
- Willing and able to provide signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
- Willing and able to comply with the requirements of the protocol and follow directions from the clinic staff
Who cannot join
- History of allergy or intolerance to ranolazine
- Any condition or concomitant medication that would have precluded the safe use of ranolazine as outlined in the prescribing information sheet (see Appendix E)
- In the judgment of the investigator, any clinically-significant ongoing medical condition that might jeopardize the patient's safety or interfere with the absorption, distribution, metabolism or excretion of the study drug
- In the judgment of the investigator, clinically-significant abnormal physical findings during screening (excluding the patient's peripheral neuropathy condition)
- Use of any experimental or investigational drug or device within 30 days prior to screening
- Pregnant or breast feeding, or (if premenopausal), not practicing an acceptable method of birth control (as detailed in Inclusion Criterion 4)
Show all 11Show fewer
- Had received prior treatment with, or investigational exposure to, ranolazine within 7 days prior to randomization
- Clinically significant hepatic impairment
- Had end-stage renal disease requiring dialysis
- Psychological or addictive disorders (not limited to, but including drug and/or alcohol dependency) that may have precluded patient consent or compliance, or that may have confounded study interpretation
- Positive pregnancy test at Baseline (pre-randomization, Day 0)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Institute of the South Clinical Research Corporation
Houma, Louisiana, 70360
About this study
Official title: A Double-blind, Placebo-controlled, Cross-over Study of Ranolazine in Patients With Coronary Artery Disease for the Treatment of Painful Polyneuropathy
This study was to determine whether ranolazine was effective in the treatment of neuropathic pain in patients with coronary artery disease.
Eligibility required neurological examination by the study doctor and assessment of the patient's pain. Eligible participants were randomized to receive blinded study medication for a total of 12 weeks.
- Being tested
- Ranolazine, Placebo
- Keywords
- Coronary Artery Disease, Pain, Peripheral Neuropathy, Polyneuropathy
- Medical subject headings
- Coronary Artery Disease, Pain, Peripheral Nervous System Diseases, Polyneuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanolazineDrug
Also called Ranexa
Ranolazine ER tablet administered orally for 6 weeks (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks).
PlaceboDrug
Placebo to match ranolazine administered twice a day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo-Ranolazine | Experimental | Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6, then ranolazine during Weeks 7 to 12. Receives: Drug: Ranolazine; Drug: Placebo |
| Ranolazine-Placebo | Experimental | Participants were randomized to receive ranolazine during Weeks 1 to 6, then placebo to match ranolazine during Weeks 7 to 12. Receives: Drug: Ranolazine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Neuropathic Pain
Reduction in patient-reported neuropathic pain (by 2 numeric levels as measured by the Numeric Pain Scale)
Measured: Baseline to Week 6
Secondary outcomes (2)
Assess Participant Quality of Life Utilizing the Short Form 36 Health Survey (SF-36v2) Questionnaire
The participant quality of life assessed utilizing the SF-36v2 questionnaire
Measured: Baseline to Week 6
Response to Thermal and Mechanical Stimuli
The participant response to thermal and mechanical stimuli as measured by the Hargreaves and Von Frey tests
Measured: Baseline to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: Lack of enrollment
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 Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Craig Walker, MD, Principal investigator, Cardiovascular Institute of the South Clinical Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832572
- Sponsor's protocol ID
- CVT 3042
- Status last verified
- May 2014
- First submitted
- 28 Jan 2009
- Last updated
- 30 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Cross-over Study of Ranolazine in Patients With Coronary Artery Disease for the Treatment of Painful Polyneuropathy
- ClinicalTrials.gov ID
- NCT00832572
- Acronym / sponsor ID
- CVT 3042
- Keywords
- Coronary Artery Disease, Pain, Peripheral Neuropathy, Polyneuropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 30 Jan 2009 (estimated)
- Results
- Posted 30 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was to determine whether ranolazine was effective in the treatment of neuropathic pain in patients with coronary artery disease.
Eligibility required neurological examination by the study doctor and assessment of the patient's pain. Eligible participants were randomized to receive blinded study medication for a total of 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo-Ranolazine | Experimental | Drug: Ranolazine, Drug: PlaceboParticipants were randomized to receive placebo to match ranolazine during Weeks 1 to 6, then ranolazine during Weeks 7 to 12. |
| Ranolazine-Placebo | Experimental | Drug: Ranolazine, Drug: PlaceboParticipants were randomized to receive ranolazine during Weeks 1 to 6, then placebo to match ranolazine during Weeks 7 to 12. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females aged ≥ 18 years
- Coronary artery disease with a clinically diagnosed peripheral neuropathy
- Willing and able to provide signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
- Willing and able to comply with the requirements of the protocol and follow directions from the clinic staff
Key exclusion criteria (11 listed)
- History of allergy or intolerance to ranolazine
- Any condition or concomitant medication that would have precluded the safe use of ranolazine as outlined in the prescribing information sheet (see Appendix E)
- In the judgment of the investigator, any clinically-significant ongoing medical condition that might jeopardize the patient's safety or interfere with the absorption, distribution, metabolism or excretion of the study drug
- In the judgment of the investigator, clinically-significant abnormal physical findings during screening (excluding the patient's peripheral neuropathy condition)
- Use of any experimental or investigational drug or device within 30 days prior to screening
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 |
|---|---|---|
| RanolazineAlso: RanexaRanolazine ER tablet administered orally for 6 weeks (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks). | Drug | Placebo-Ranolazine, Ranolazine-Placebo |
| PlaceboPlacebo to match ranolazine administered twice a day for 6 weeks | Drug | Placebo-Ranolazine, Ranolazine-Placebo |
Primary outcome
Reduction in Neuropathic Pain
Time frame: Baseline to Week 6
Reduction in patient-reported neuropathic pain (by 2 numeric levels as measured by the Numeric Pain Scale)
2 secondary outcomes
Assess Participant Quality of Life Utilizing the Short Form 36 Health Survey (SF-36v2) Questionnaire
Time frame: Baseline to Week 6
Response to Thermal and Mechanical Stimuli
Time frame: Baseline to Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The Neuropathy Association, a public, non-profit organization providing information and support for patients with neuropathyLink provided by the sponsor.
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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.
Craig Walker, MD principal investigator
Cardiovascular Institute of the South Clinical Research Corporation
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 Ranolazine in people with Coronary Artery Disease and Pain, run by Gilead Sciences 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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 30 Jun 2014. 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?
Yes. Results are posted in the registry (first posted 30 Jun 2014). 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?
Reduction in Neuropathic Pain (time frame: Baseline to Week 6). 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 30 Jun 2014.