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Generated: December 17, 2018

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CLINICAL TRIALS PROFILE FOR PROCARDIA

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Clinical Trials for Procardia

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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Procardia

Condition Name

Condition Name for Procardia
Intervention Trials
Hypertension in Postpartum 1
Hypertension 1
Healthy Volunteers 1
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Condition MeSH

Condition MeSH for Procardia
Intervention Trials
Hyperplasia 1
Adrenogenital Syndrome 1
Pre-Eclampsia 1
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Clinical Trial Locations for Procardia

Trials by Country

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

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

Clinical Trial Phase

Clinical Trial Phase for Procardia
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
Clinical Trial Phase Trials
Completed 2
Enrolling by invitation 1
Not yet recruiting 1
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Clinical Trial Sponsors for Procardia

Sponsor Name

Sponsor Name for Procardia
Sponsor Trials
Bayer 1
University of California, San Diego 1
Merck Sharp & Dohme Corp. 1
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Sponsor Type

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

UBS
Farmers Insurance
Covington
US Army
Colorcon
Express Scripts
Mallinckrodt
Teva
Harvard Business School

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