Efficacy Study of Cardizem in Pulmonary Arterial Hypertension
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|ClinicalTrials.gov Identifier: NCT01645826|
Recruitment Status : Withdrawn (no participants agreed to enroll since study start)
First Posted : July 20, 2012
Last Update Posted : November 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Arterial Hypertension Primary Pulmonary Hypertension Pulmonary Arterial Hypertension Familial Primary Pulmonary Hypertension||Drug: Diltiazem Hydrochloride Drug: Sugar Pill||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Calcium Channel Blockers in Nitric Oxide Non-responder Pulmonary Arterial Hypertension.|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
The study agent will be Diltiazem and will start at 60 mg po BID then titrated up every two weeks until at a maximum dose of 180mg po BID.
Drug: Diltiazem Hydrochloride
The study agent will be diltiazem and will start at 60 mg po BID then titrated up very two weeks until at a maximum maintenance dose of 180mg po BID for six weeks.
Placebo Comparator: Sugar Pill
The placebo group of patients will be treated with Drug A (sugar pill) PO bid and titrated up every two weeks for next titration dose (actually will be an unchanged concentration).
Drug: Sugar Pill
The placebo group of patients will be treated with sugar pill PO bid and return every two weeks for next titration dose (actually will be an unchanged concentration).
Other Name: placebo
- Six Minute Walk Distance [ Time Frame: 12 weeks ]
- Dyspnea Score [ Time Frame: 12 weeks ]
- Quality of Life Score [ Time Frame: 12 weeks ]
- Pulse Oximetry [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01645826
|United States, Florida|
|University of South Florida|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Mark Rumbak, MD||University of South Florida|