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Last Updated: January 26, 2023

CLINICAL TRIALS PROFILE FOR PROCARDIA XL


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All Clinical Trials for Procardia Xl

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000102 ↗ Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets Completed National Center for Research Resources (NCRR) Phase 1/Phase 2 1969-12-31 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).
NCT00593463 ↗ Drug Discrimination in Methadone-Maintained Humans Study 1 Completed University of Arkansas Phase 1 2006-09-01 This study involves giving psychoactive drugs intramuscularly (injected into the muscle of the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the difference between one drug and another, as well as measuring the effects of the drugs on mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each subject will receive 2-4 of the listed interventions.
NCT01348880 ↗ Vardenafil ODT (Orally Disintegrating Tablet) - Nifedipine Interaction Study Completed GlaxoSmithKline Phase 1 2011-05-01 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 2011-05-01 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 2011-05-01 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.
NCT02438371 ↗ Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor Terminated The University of Texas Health Science Center, Houston Phase 4 2015-05-01 Tocolytic agents are used for the treatment of preterm labor. It is unclear whether combination treatments of two tocolytic agents are more effective in stopping preterm labor compared to one. Therefore, the investigators propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor
NCT02933593 ↗ Changes in Central Arterial Pressure When Comparing ACOG Hypertensive Urgency Protocols Withdrawn St. Louis University N/A 2016-08-01 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Procardia Xl

Condition Name

Condition Name for Procardia Xl
Intervention Trials
Preeclampsia 3
Hypertension in Pregnancy 2
Erectile Dysfunction 1
Healthy Volunteers 1
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Condition MeSH

Condition MeSH for Procardia Xl
Intervention Trials
Pre-Eclampsia 4
Hypertension 2
Obstetric Labor, Premature 2
Hypertension, Pregnancy-Induced 2
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Clinical Trial Locations for Procardia Xl

Trials by Country

Trials by Country for Procardia Xl
Location Trials
United States 11
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Trials by US State

Trials by US State for Procardia Xl
Location Trials
Tennessee 3
Wisconsin 1
New York 1
California 1
Missouri 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 2
Phase 1/Phase 2 1
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for Procardia Xl
Clinical Trial Phase Trials
Completed 5
Terminated 2
Withdrawn 2
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Clinical Trial Sponsors for Procardia Xl

Sponsor Name

Sponsor Name for Procardia Xl
Sponsor Trials
GlaxoSmithKline 1
University of California, San Francisco 1
Merck Sharp & Dohme Corp. 1
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Sponsor Type

Sponsor Type for Procardia Xl
Sponsor Trials
Other 14
Industry 3
U.S. Fed 1
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