Efficacy Study of Cardizem in Pulmonary Arterial Hypertension
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|ClinicalTrials.gov Identifier: NCT01645826|
Recruitment Status : Unknown
Verified September 2013 by Mark Rumbak, University of South Florida.
Recruitment status was: Recruiting
First Posted : July 20, 2012
Last Update Posted : September 9, 2013
|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)|
|Estimated Enrollment :||40 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|
|Estimated Primary Completion Date :||November 2014|
|Estimated Study Completion Date :||November 2014|
U.S. FDA Resources
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
|Contact: Mark Rumbak, MDemail@example.com|
|Contact: Kimberley Cao, MDfirstname.lastname@example.org|
|United States, Florida|
|University of South Florida||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Mark Rumbak, MD 814-974-2201 email@example.com|
|Contact: Cao Kimberley, MD 813-974-2201 firstname.lastname@example.org|
|Principal Investigator: Mark Rumbak, MD|
|Sub-Investigator: Kimberley Cao, MD|
|Sub-Investigator: Chakrapol Sriaroon, MD|
|Sub-Investigator: David Solomon, MD|
|Principal Investigator:||Mark Rumbak, MD||University of South Florida|