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A Study of the Onset and Offset of Antiplatelet Effects Comparing Ticagrelor, Clopidogrel, and Placebo With Aspirin
This study has been completed.

First Received on September 10, 2007.   Last Updated on January 12, 2012   History of Changes
Sponsor: AstraZeneca
Information provided by (Responsible Party): AstraZeneca
ClinicalTrials.gov Identifier: NCT00528411
  Purpose

The purpose of this study is to see how Ticagrelor, a new oral reversible anti-platelet medication, affects platelets. Anti-platelet agents are medications that block the formation of blood clots by preventing the clumping of platelets. Blood clots prevent us from bleeding, but when they form inside the arteries their formation is linked to a risk of medical problems such as heart attack and stroke. This study investigated how long it takes for Ticagrelor to begin working and how long it takes for it to stop working after the last dose of drug. Ticagrelor will be compared to clopidogrel, an established anti-platelet treatment for preventing blood clots, and placebo plus Aspirin.


Condition Intervention Phase
Coronary Artery Disease
 Drug: Ticagrelor Tablets
Drug: Clopidogrel (over encapsulated) capsule
Drug: Aspirin Tablets
 Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-centre Randomised, Double-blind, Double-dummy Parallel Group Study of the Onset and Offset of Antiplatelet Effects of Ticagrelor Compared With Clopidogrel and Placebo With Aspirin as Background Therapy in Patients With Stable Coronary Artery Disease (CAD)

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease
Drug Information available for: Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose [ Time Frame: At 2 hours after first dose of study drug ] [ Designated as safety issue: No ]
    IPA(%)=(PAb-PAt)/PAb*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.

  • Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug [ Time Frame: 4 to 72 Hours after last dose of study drug ] [ Designated as safety issue: No ]
    IPA(%)=(PAb-PAt)/PAb*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. The unit for the slope of IPA curve is percent/hour.


Secondary Outcome Measures:
  • Final Extent IPA Induced by 20 µM ADP at 0.5 Hours After First Dose [ Time Frame: 0.5 hours after first dose ] [ Designated as safety issue: No ]
    IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.

  • Final Extent IPA Induced by 20 µM ADP at 1 Hour After First Dose [ Time Frame: 1 hour after first dose ] [ Designated as safety issue: No ]
    IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.

  • Final Extent IPA Induced by 20 µM ADP at 4 Hours After First Dose [ Time Frame: 4 hours after first dose ] [ Designated as safety issue: No ]
    IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.

  • Final Extent IPA Induced by 20 µM ADP at 8 Hours After First Dose [ Time Frame: 8 hours after first dose ] [ Designated as safety issue: No ]
    IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.

  • Final Extent IPA Induced by 20 µM ADP at 24 Hours After First Dose [ Time Frame: 24 hours after first dose ] [ Designated as safety issue: No ]
    IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.

  • Final Extent IPA Induced by 20 µM ADP at 0 Hour Before Last Dose [ Time Frame: 0 hour before last dose ] [ Designated as safety issue: No ]
    IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.

  • Final Extent IPA Induced by 20 µM ADP at 2 Hours After Last Dose [ Time Frame: 2 hours after last dose ] [ Designated as safety issue: No ]
    IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.

  • Final Extent IPA Induced by 20 µM ADP at 4 Hours After Last Dose [ Time Frame: 4 hours after last dose ] [ Designated as safety issue: No ]
    IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.

  • Final Extent IPA Induced by 20 µM ADP at 8 Hours After Last Dose [ Time Frame: 8 hours after last dose ] [ Designated as safety issue: No ]
    IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.

  • Final Extent IPA Induced by 20 µM ADP at 24 Hours After Last Dose [ Time Frame: 24 hours after last dose ] [ Designated as safety issue: No ]
    IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.

  • Final Extent IPA Induced by 20 µM ADP at 48 Hours After Last Dose [ Time Frame: 48 hours after last dose ] [ Designated as safety issue: No ]
    IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.

  • Final Extent IPA Induced by 20 µM ADP at 72 Hours After Last Dose [ Time Frame: 72 hours after last dose ] [ Designated as safety issue: No ]
    IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.

  • Final Extent IPA Induced by 20 µM ADP at 120 Hours - Day 5 After Last Dose [ Time Frame: 120 hours - Day 5 after last dose ] [ Designated as safety issue: No ]
    IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.

  • Final Extent IPA Induced by 20 µM ADP at 168 Hours - Day 7 After Last Dose [ Time Frame: 168 hours - Day 7 after last dose ] [ Designated as safety issue: No ]
    IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference of baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.

  • Final Extent IPA Induced by 20 µM ADP at 240 Hours - Day 10 After Last Dose [ Time Frame: 240 hours - Day 10 after last dose ] [ Designated as safety issue: No ]
    IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.

  • Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    FEV1 is measured by Spirometry, the unit is Liter.

  • Cardiopulmonary Parameters at Post 6-week Treatment: FEV1 [ Time Frame: 6-week post treatment ] [ Designated as safety issue: Yes ]
    FEV1 is measured by Spirometry, the unit is Liter.

  • Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    FVC is measured by Spirometry, the unit is Liter.

  • Cardiopulmonary Parameters at Post 6-week Treatment: FVC [ Time Frame: 6-week post treatment ] [ Designated as safety issue: Yes ]
    FVC is measured by Spirometry, the unit is Liter.

  • Cardiopulmonary Parameters at Baseline: Ratio of Forced Expiratory Volume in 1 Second Over Forced Vital Capacity (FEV1/FVC Ratio) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.

  • Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio [ Time Frame: 6-week post treatment ] [ Designated as safety issue: Yes ]
    FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.

  • Cardiopulmonary Parameters at Baseline: Mean Forced Expiratory Flow Between 25% and 75% of the FVC (FEF25-75) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    FEF25-75 is measured by Spirometry, the unit is Liter/Second.

  • Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75 [ Time Frame: 6-week post treatment ] [ Designated as safety issue: Yes ]
    FEF25-75 is measured by Spirometry, the unit is Liter/Second.

  • Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    FRC is measured by Body Box Plethysmography, the unit is Liter.

  • Cardiopulmonary Parameters Post 6-week Treatment: FRC [ Time Frame: 6-week post treatment ] [ Designated as safety issue: Yes ]
    FRC is measured by Body Box Plethysmography, the unit is Liter.

  • Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    TLC is measured by Body Box Plethysmography, the unit is Liter.

  • Cardiopulmonary Parameters Post 6-week Treatment: TLC [ Time Frame: 6-week post treatment ] [ Designated as safety issue: Yes ]
    TLC is measured by Body Box Plethysmography, the unit is Liter.

  • Cardiopulmonary Parameters at Baseline: Residual Volume (RV) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    RV is measured by Body Box Plethysmography, the unit is Liter.

  • Cardiopulmonary Parameters Post 6-week Treatment: RV [ Time Frame: 6-week post treatment ] [ Designated as safety issue: Yes ]
    RV is measured by Body Box Plethysmography, the unit is Liter.

  • Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute

  • Cardiopulmonary Parameters Post 6-week Treatment: VE [ Time Frame: 6-week post treatment ] [ Designated as safety issue: Yes ]
    VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute

  • Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.

  • Cardiopulmonary Parameters Post 6-week Treatment: RR [ Time Frame: 6-week post treatment ] [ Designated as safety issue: Yes ]
    RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.

  • Cardiopulmonary Parameters at Baseline: Tidal Volume (VT) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    VT is measured by Body Box Plethysmography, the unit is Liter/Minute.

  • Cardiopulmonary Parameters Post 6-week Treatment: VT [ Time Frame: 6-week post treatment ] [ Designated as safety issue: Yes ]
    VT is measured by Body Box Plethysmography, the unit is Liter/Minute.

  • Cardiopulmonary Parameters at Baseline: Single Breath Diffusing Capacity for the Lungs Using Carbon Monoxide (DLCOSB) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    DLCOSB is measured by Body Box Plethysmography, the unit is Percent.

  • Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB [ Time Frame: 6-week post treatment ] [ Designated as safety issue: Yes ]
    DLCOSB is measured by Body Box Plethysmography, the unit is Percent.

  • Cardiopulmonary Parameters at Baseline: Ejection Fraction (EF) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle.

  • Cardiopulmonary Parameters Post 6-week Treatment: EF [ Time Frame: 6-week post treatment ] [ Designated as safety issue: Yes ]
    EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle.

  • Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    NT-proBNP is measured by clinical lab, the unit is pg/mL.

  • Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP [ Time Frame: 6-week post treatment ] [ Designated as safety issue: Yes ]
    NT-proBNP is measured by clinical lab, the unit is pg/mL.

  • Cardiopulmonary Parameters at Baseline: Blood Oxygen Saturation Measured by Pulse Oximetry (SpO2) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin.

  • Cardiopulmonary Parameters Post 6-week Treatment: SpO2 [ Time Frame: 6-week post treatment ] [ Designated as safety issue: Yes ]
    SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin.


Enrollment: 123
Study Start Date: October 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Aspirin + Placebo
 Drug: Aspirin Tablets
Oral, 75 mg to 100 mg once daily. Aspirin obtained locally by the investigator, according to local practice. The dose remained constant throughout the study.
Other Name: ASA
Active Comparator: 2
Aspirin + clopidogrel
 Drug: Clopidogrel (over encapsulated) capsule
Oral 75 mg; 600 mg loading dose followed by 75 mg once daily (ODD)
Other Names:
  • Plavix
  • Clopidogrel Bisulfate
Drug: Aspirin Tablets
Oral, 75 mg to 100 mg once daily. Aspirin obtained locally by the investigator, according to local practice. The dose remained constant throughout the study.
Other Name: ASA
Experimental: 3
Aspirin + Ticagrelor
 Drug: Ticagrelor Tablets
Oral, 90 mg; 180 mg loading dose followed by 90 mg twice daily (BD)
Drug: Aspirin Tablets
Oral, 75 mg to 100 mg once daily. Aspirin obtained locally by the investigator, according to local practice. The dose remained constant throughout the study.
Other Name: ASA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented stable Coronary Artery Disease (stable angina, previous MI history, previous history of revascularization);
  • Females of child bearing potential must have a negative pregnancy test prior to receiving study drug and be willing to use a hormonal contraceptive in addition to double barrier contraception

Exclusion Criteria:

  • History of Acute Coronary Syndromes within 12 months of screening or need for revascularization (angioplasty or Coronary Artery Bypass Graft (CABG))
  • History of liver or kidney disease
  • Have increased bleeding risk, eg, recent gastrointestinal bleed, uncontrolled high blood pressure, low platelet count, recent major trauma
  • History of intolerance or allergy to Aspirin or clopidogrel
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528411

Locations
United States, Louisiana
Research Site
Baton Rouge, Louisiana, United States
United States, Maryland
Research Site
Baltimore, Maryland, United States
Research Site
Towson, Maryland, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, South Dakota
Research Site
Rapid City, South Dakota, United States
United States, Texas
Research Site
Houston, Texas, United States
United Kingdom
Research Site
Sheffield, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Philip Sager, MD AstraZeneca
Principal Investigator: Paul Gurbel, MD Platelet & Thrombosis Research, LLC
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Tantry US, Bliden KP, Wei C, Storey RF, Armstrong M, Butler K, Gurbel PA. First analysis of the relation between CYP2C19 genotype and pharmacodynamics in patients treated with ticagrelor versus clopidogrel: the ONSET/OFFSET and RESPOND genotype studies. Circ Cardiovasc Genet. 2010 Dec 1;3(6):556-66. Epub 2010 Nov 15.
Storey RF, Bliden KP, Patil SB, Karunakaran A, Ecob R, Butler K, Teng R, Wei C, Tantry US, Gurbel PA; ONSET/OFFSET Investigators. Incidence of dyspnea and assessment of cardiac and pulmonary function in patients with stable coronary artery disease receiving ticagrelor, clopidogrel, or placebo in the ONSET/OFFSET study. J Am Coll Cardiol. 2010 Jul 13;56(3):185-93.
Gurbel PA, Bliden KP, Butler K, Tantry US, Gesheff T, Wei C, Teng R, Antonino MJ, Patil SB, Karunakaran A, Kereiakes DJ, Parris C, Purdy D, Wilson V, Ledley GS, Storey RF. Randomized double-blind assessment of the ONSET and OFFSET of the antiplatelet effects of ticagrelor versus clopidogrel in patients with stable coronary artery disease: the ONSET/OFFSET study. Circulation. 2009 Dec 22;120(25):2577-85. Epub 2009 Nov 18.

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00528411     History of Changes
Other Study ID Numbers: D5130C00048
Study First Received: September 10, 2007
Results First Received: January 27, 2011
Last Updated: January 12, 2012
Health Authority: United States: Food and Drug Administration;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Coronary artery disease
CAD
heart attack
stable angina
Stable coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Ticlopidine
Clopidogrel
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012



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