HypercholesterolemiaPhase 2NCT00404001
Study of Oral MD-0727 Administered to Patients With Primary Hypercholesterolemia
A Phase 2 study testing MD-0727 in people with Hypercholesterolemia, run by Ironwood Pharmaceuticals, Inc. at 20 sites in United States.
Trial summary
The primary objectives of this study are to evaluate the safety of MD-0727 in patients with primary hypercholesterolemia and to determine the low density lipoprotein cholesterol (LDL-C) lowering effect and dose-response of MD-0727 in patients with primary hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- MD-0727
- How many people
- 150 participants
- Where
- 20 sitesUnited States
- Study dates
- Nov 2006to Jul 2007
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is male or non-pregnant, non-breastfeeding female, at least 18 years of age
- Patient must agree to use contraception and/or birth control if sexually active
- Patient may not be on lipid-lowering therapies at least 6 weeks prior to study and must have a fasting LDL-C 130 mg/dl or greater at Screening
- Patient must have an average of two fasting LDL-C measures greater than/equal to 130 mg/dl but less than/equal to 210 mg/dl with a difference in the two measures less than/equal to 15%. Patient may not have a fasting serum triglyceride less than 300 mg/dl during Pre-treatment Period
- Patient's BMI must be greater than/equal to 18.5 but less than 35.0 at Screening
- Patient must complete a physical exam, 12-lead ECG, and other laboratory tests (including pregnancy test) with no clinically-significant findings prior to the first dose of study medication
- Patient agrees to comply with the TLC diet
- Patient completes a 6-week washout of previous lipid-lowering medication including over-the-counter products
Who cannot join
- Patient has a medical condition that is prohibited per protocol or a condition that the Investigator believes may limit the patient's ability to participate in the study
- Patient has a TSH level >1.5 X the upper limit of normal
- Patient has history of cardiovascular or coronary artery disease, uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins, or patient has history of NYHA Class III or IV congestive heart failure
- Patient is diabetic or presents with fasting blood glucose greater than/equal to 126 mg/dl at any time prior to randomization
- Patient has uncontrolled hypertension with a systolic blood pressure greater than/equal to 180 mm Hg or diastolic blood pressure greater than/equal to 110 mmg Hg at two study visits prior to the first dose of study medication
- Patient has a 10-year CHD risk of > 20%
Show all 9Show fewer
- Patient has ALT or AST > 1.5 X the upper limit of normal prior to randomization
- Patient has a history of alcohol or drug abuse within 12 months of Screening
- Patient has used a prohibited medication (per protocol) during the 14-day Pre-treatment Visit
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Microbia Investigational Site
Birmingham, Alabama
Microbia Investigational Site
Bristol, Tennessee
Microbia Investigational Site
Charleston, South Carolina
Microbia Investigational Site
Chicago, Illinois
Microbia Investigational Site
Cincinnati, Ohio
Microbia Investigational Site
Edina, Minnesota
Microbia Investigational Site
Indianapolis, Indiana
Microbia Investigational Site
Kansas City, Missouri
Microbia Investigational Site
Lakewood, Washington
Microbia Investigational Site
Los Angeles, California
Microbia Investigational Site
Louisville, Kentucky
Microbia Investigational Site
Marion, Ohio
Microbia Investigational Site
New Port Richey, Florida
Microbia Investigational Site
Olympia, Washington
Microbia Investigational Site
Overland, Kansas
Microbia Investigational Site
Richmond, Virginia
Microbia Investigational Site
San Antonio, Texas
Microbia Investigational Site
Statesville, North Carolina
Microbia Investigational Site
Walnut Creek, California
Microbia Investigational Site
Winston-Salem, North Carolina
About this study
Official title: A Phase 2, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Range-Finding Study of the Safety and Efficacy of Orally Administered MD-0727 in Patients With Primary Hypercholesterolemia
The primary objectives of this study are to evaluate the safety of MD-0727 in patients with primary hypercholesterolemia and to determine the low density lipoprotein cholesterol (LDL-C) lowering effect and dose-response of MD-0727 in patients with primary hypercholesterolemia.
- Conditions
- Hypercholesterolemia
- Being tested
- MD-0727
- Keywords
- Microbia, MD-0727, Primary Hypercholesterolemia, Hypercholesterolemia, Hyperlipidemia, Dyslipidemia, Cholesterol, LDL
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MD-0727Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Low density lipoprotein cholesterol (LDL-C)
Secondary outcomes (1)
Total cholesterol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2006 (estimated)
- Study startNov 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Microbia Medical Affairs, Study director, Microbia, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404001
- Sponsor's protocol ID
- MCP-104-201
- Status last verified
- Sep 2007
- First submitted
- 22 Nov 2006
- Last updated
- 1 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Range-Finding Study of the Safety and Efficacy of Orally Administered MD-0727 in Patients With Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00404001
- Acronym / sponsor ID
- MCP-104-201
- Conditions
- Hypercholesterolemia
- Keywords
- Microbia, MD-0727, Primary Hypercholesterolemia, Hypercholesterolemia, Hyperlipidemia, Dyslipidemia, Cholesterol, LDL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 27 Nov 2006 (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 primary objectives of this study are to evaluate the safety of MD-0727 in patients with primary hypercholesterolemia and to determine the low density lipoprotein cholesterol (LDL-C) lowering effect and dose-response of MD-0727 in patients with primary hypercholesterolemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is male or non-pregnant, non-breastfeeding female, at least 18 years of age
- Patient must agree to use contraception and/or birth control if sexually active
- Patient may not be on lipid-lowering therapies at least 6 weeks prior to study and must have a fasting LDL-C 130 mg/dl or greater at Screening
- Patient must have an average of two fasting LDL-C measures greater than/equal to 130 mg/dl but less than/equal to 210 mg/dl with a difference in the two measures less than/equal to 15%. Patient may not have a fasting serum triglyceride less than 300 mg/dl during Pre-treatment Period
- Patient's BMI must be greater than/equal to 18.5 but less than 35.0 at Screening
Key exclusion criteria (9 listed)
- Patient has a medical condition that is prohibited per protocol or a condition that the Investigator believes may limit the patient's ability to participate in the study
- Patient has a TSH level >1.5 X the upper limit of normal
- Patient has history of cardiovascular or coronary artery disease, uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins, or patient has history of NYHA Class III or IV congestive heart failure
- Patient is diabetic or presents with fasting blood glucose greater than/equal to 126 mg/dl at any time prior to randomization
- Patient has uncontrolled hypertension with a systolic blood pressure greater than/equal to 180 mm Hg or diastolic blood pressure greater than/equal to 110 mmg Hg at two study visits prior to the first dose of study medication
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 |
|---|---|---|
| MD-0727 | Drug | – |
Primary outcome
Low density lipoprotein cholesterol (LDL-C)
1 secondary outcome
Total cholesterol
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 1 Oct 2007.
Related trials for Hypercholesterolemia
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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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.
Microbia Medical Affairs study director
Microbia, Inc.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MD-0727 in people with Hypercholesterolemia, run by Ironwood Pharmaceuticals, Inc. at 20 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 8 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 1 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Low density lipoprotein cholesterol (LDL-C). 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 1 Oct 2007.