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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01148836 |
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Date of registration:
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19/03/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Coenzyme Q-10 and Pulmonary Arterial Hypertension
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Scientific title:
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Coenzyme Q-10 in the Treatment of Pulmonary Arterial Hypertension |
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Date of first enrolment:
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January 2010 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01148836 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Jackie Sharp, CNP |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Cleveland Clinic |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Males and Females age equal to or greater than 18 not to exceed 65.
- Patients with PAH Class 1 (Venice 2003)
- PAH medications must not have changed for the last two months.
- Women of child-bearing age must use a double-barrier local contraception until
completion of study.
- Subjects must demonstrate understanding of study and sign informed consent and have a
reliable method of communication for contact and the ability to comply with the study
requirements.
Exclusion Criteria:
- Participation in any other studies at the time of enrollment
- History of any significant illness within four weeks of starting Coenzyme Q-10
- Hepatic insufficiency (transaminase levels >4 fold the upper limit of normal or
bilirubin >2 fold the upper limit of normal).
- Renal insufficiency (creatinine >2)
- Pregnancy,breast-feeding or lack of safe contraception.
- Acute heart failure
- Known allergy to the study drug or drugs similar to the study drug
- History of drug or alcohol abuse within last 12 months
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Dietary Supplement: Coenzyme Q-10 in Normal Control subjects
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Dietary Supplement: Coenzyme Q-10 in Pulmonary Hypertension subjects
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Primary Outcome(s)
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Right Atrial Pressure
[Time Frame: before and after three months of CoQ]
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Left Ventricular End Diastolic Volume
[Time Frame: before and after three months of CoQ]
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Right Ventricular Outflow
[Time Frame: before and after three months of CoQ]
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Tricuspid Regurgitation Grade
[Time Frame: before and after three months of CoQ]
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Right Ventricle Myocardial Performance
[Time Frame: before and after three months of CoQ]
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Secondary Outcome(s)
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Red Blood Cell Distribution Width
[Time Frame: before and after three months of CoQ]
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Mean Corpuscular Hemoglobin
[Time Frame: before and after three months of CoQ]
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Red Blood Cells
[Time Frame: before and after three months of CoQ]
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Hematocrit
[Time Frame: before and after three months of CoQ]
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Hemoglobin
[Time Frame: before and after three months of CoQ]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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