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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR PROCARDIA XL

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Clinical Trials for Procardia Xl

Trial ID Title Status Sponsor Phase Summary
NCT00000102 Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets Completed National Center for Research Resources (NCRR) Phase 1/Phase 2 This study will test the ability of extended release nifedipine (Procardia XL), a blood pressure medication, to permit a decrease in the dose of glucocorticoid medication children take to treat congenital adrenal hyperplasia (CAH).
NCT01348880 Vardenafil ODT (Orally Disintegrating Tablet) - Nifedipine Interaction Study Completed GlaxoSmithKline Phase 1 The study will be conducted as a multi-center, randomized, double-blinded, placebo controlled, crossover design. The investigational drug (vardenafil ODT (Orally Disintegrating Tablet)/placebo) will be given as a single administration at a dose of 10 mg vardenafil ODT during Period 1 or 2; the blinded matching placebo will be given as a single administration during the opposing period. The random code will determine the order of active drug (vardenafil ODT) and placebo for each subject. Blood pressure and heart rate profiles will be recorded by automated device pre-dose for 8 hours post-dose during Periods 1 and 2. The non investigational drug product (vasodilator), Procardia XL, will be background treatment for hypertension, taken daily by each subject. All subjects must be stable on the vasodilator for at least 4 weeks prior to Day 1 of Period 1. Special conditions for this study include the requirement that all subjects will be male, are between the ages of 65 and 80 years, and will have a diagnosis of erectile dysfunction (ED), as well as hypertension. Planned sample size will be 40 subjects evaluable for the primary analysis. Of the 40 subjects valid for this analysis, 20 will be between the ages of 65 and 69 years, and 20 subjects will be between the ages of 70 and 80 years. The total duration of the study will be approximately one year from first subject treated to last subject treated, including replacement of any subjects who fail to complete both periods of crossover dosing.
NCT01348880 Vardenafil ODT (Orally Disintegrating Tablet) - Nifedipine Interaction Study Completed Merck Sharp & Dohme Corp. Phase 1 The study will be conducted as a multi-center, randomized, double-blinded, placebo controlled, crossover design. The investigational drug (vardenafil ODT (Orally Disintegrating Tablet)/placebo) will be given as a single administration at a dose of 10 mg vardenafil ODT during Period 1 or 2; the blinded matching placebo will be given as a single administration during the opposing period. The random code will determine the order of active drug (vardenafil ODT) and placebo for each subject. Blood pressure and heart rate profiles will be recorded by automated device pre-dose for 8 hours post-dose during Periods 1 and 2. The non investigational drug product (vasodilator), Procardia XL, will be background treatment for hypertension, taken daily by each subject. All subjects must be stable on the vasodilator for at least 4 weeks prior to Day 1 of Period 1. Special conditions for this study include the requirement that all subjects will be male, are between the ages of 65 and 80 years, and will have a diagnosis of erectile dysfunction (ED), as well as hypertension. Planned sample size will be 40 subjects evaluable for the primary analysis. Of the 40 subjects valid for this analysis, 20 will be between the ages of 65 and 69 years, and 20 subjects will be between the ages of 70 and 80 years. The total duration of the study will be approximately one year from first subject treated to last subject treated, including replacement of any subjects who fail to complete both periods of crossover dosing.
NCT01348880 Vardenafil ODT (Orally Disintegrating Tablet) - Nifedipine Interaction Study Completed Bayer Phase 1 The study will be conducted as a multi-center, randomized, double-blinded, placebo controlled, crossover design. The investigational drug (vardenafil ODT (Orally Disintegrating Tablet)/placebo) will be given as a single administration at a dose of 10 mg vardenafil ODT during Period 1 or 2; the blinded matching placebo will be given as a single administration during the opposing period. The random code will determine the order of active drug (vardenafil ODT) and placebo for each subject. Blood pressure and heart rate profiles will be recorded by automated device pre-dose for 8 hours post-dose during Periods 1 and 2. The non investigational drug product (vasodilator), Procardia XL, will be background treatment for hypertension, taken daily by each subject. All subjects must be stable on the vasodilator for at least 4 weeks prior to Day 1 of Period 1. Special conditions for this study include the requirement that all subjects will be male, are between the ages of 65 and 80 years, and will have a diagnosis of erectile dysfunction (ED), as well as hypertension. Planned sample size will be 40 subjects evaluable for the primary analysis. Of the 40 subjects valid for this analysis, 20 will be between the ages of 65 and 69 years, and 20 subjects will be between the ages of 70 and 80 years. The total duration of the study will be approximately one year from first subject treated to last subject treated, including replacement of any subjects who fail to complete both periods of crossover dosing.
NCT02933593 Changes in Central Arterial Pressure When Comparing ACOG Hypertensive Urgency Protocols Enrolling by invitation St. Louis University N/A The investigators plan to monitor the central blood pressure in women with severely elevated blood pressures (160/110) in pregnancy in the acute setting. Currently ACOG recommends 3 different options for blood pressure control, however no one has studied how these medications affect the central pressures, only peripheral blood pressure.
NCT03100838 Drug Interaction With Proton Pump Inhibitors for Nifedipine ER Tablets Recruiting BioPharma Services, Inc Phase 1 The purpose of this study is to measure the amount of study drug present in blood after being administered a generic version of nifedipine extended-release tablets, 60 mg (Valeant Pharmaceuticals, LLC) and brand-name version PROCARDIA XL extended-release tablets, 60 mg (Pfizer Inc.) individually and in presence of stomach acid reducing drug (antacid), omeprazole/sodium bicarbonate capsules, 40 mg/1100 mg (generic) on separate occasions, on an empty stomach. This study also involves administrations of an FDA-cleared capsule, SmartPill™, which will measure stomach acid, prior to each study arm.
NCT03100838 Drug Interaction With Proton Pump Inhibitors for Nifedipine ER Tablets Recruiting Food and Drug Administration (FDA) Phase 1 The purpose of this study is to measure the amount of study drug present in blood after being administered a generic version of nifedipine extended-release tablets, 60 mg (Valeant Pharmaceuticals, LLC) and brand-name version PROCARDIA XL extended-release tablets, 60 mg (Pfizer Inc.) individually and in presence of stomach acid reducing drug (antacid), omeprazole/sodium bicarbonate capsules, 40 mg/1100 mg (generic) on separate occasions, on an empty stomach. This study also involves administrations of an FDA-cleared capsule, SmartPill™, which will measure stomach acid, prior to each study arm.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Procardia Xl

Condition Name

Condition Name for Procardia Xl
Intervention Trials
Erectile Dysfunction 1
Congenital Adrenal Hyperplasia 1
Obstetric Labor, Premature 1
Hypertension in Pregnancy 1
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Condition MeSH

Condition MeSH for Procardia Xl
Intervention Trials
Adrenocortical Hyperfunction 1
Hypertension, Pregnancy-Induced 1
Adrenal Hyperplasia, Congenital 1
Hypertension 1
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Clinical Trial Locations for Procardia Xl

Trials by Country

Trials by Country for Procardia Xl
Location Trials
United States 5
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Trials by US State

Trials by US State for Procardia Xl
Location Trials
California 1
Missouri 1
Tennessee 1
Florida 1
South Carolina 1
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Clinical Trial Progress for Procardia Xl

Clinical Trial Phase

Clinical Trial Phase for Procardia Xl
Clinical Trial Phase Trials
Phase 4 1
Phase 1/Phase 2 1
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Procardia Xl
Clinical Trial Phase Trials
Completed 2
Active, not recruiting 1
Recruiting 1
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Clinical Trial Sponsors for Procardia Xl

Sponsor Name

Sponsor Name for Procardia Xl
Sponsor Trials
GlaxoSmithKline 1
University of California, Davis 1
National Center for Research Resources (NCRR) 1
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Sponsor Type

Sponsor Type for Procardia Xl
Sponsor Trials
Other 8
Industry 3
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Fish and Richardson
Baxter
McKesson
Deloitte
Cerilliant
Teva
Daiichi Sankyo
Covington

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