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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT01757808
Date of registration: 26/04/2012
Prospective Registration: No
Primary sponsor: University of Chicago
Public title: A Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial Hypertension
Scientific title: A Phase I Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial Hypertension
Date of first enrolment: August 2011
Target sample size: 12
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01757808
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     Mardi Gomberg-Maitland, MD
Address: 
Telephone:
Email:
Affiliation:  University of Chicago
Key inclusion & exclusion criteria

Inclusion Criteria:

- All subjects age 18-72 yrs will have a diagnosis of PAH. PAH as defined as idiopathic
PAH, heritable PAH or PAH associated with collagen vascular disease, congenital heart
disease (repaired), or anorexigen use. A history of PAH as defined by hemodynamics at
diagnosis by right heart catheterization defined as: mean PAP >25 mmHg with a normal
PCWP < 15 mm Hg at rest and a PVR >3 Wood units.

- Baseline 6MW >150 meters

- Patients will be receiving FDA approved PAH monotherapy or dual therapy medications:
including, ambrisentan (5,10mg), sildenafil (60-240mg), tadalafil (40mg),
epoprostenol, treprostinil, or iloprost at stable doses for >90days.

- Receiving conventional therapy as clinically indicated (oxygen, calcium channel
blockers, digoxin) with dose that is unchanged in the preceding 30 days prior to
enrollment. This is excluding anticoagulants (warfarin) as the patient's dose may not
be stable if the patient is having a cardiac catheterization at baseline within 30
days of enrollment and warfarin is being held.

Exclusion Criteria:

- PAH Category II-IV and Category I associated with all other etiologies: HIV,
portopulmonary disease

- All subjects on monotherapy calcium blockers as "calcium blocker responders"
irrespective of therapy

- All subjects receiving CY3P4 inducer (i.e. bosentan)

- Subjects with pulmonary hypertension due to significant interstitial lung disease,
chronic obstructive pulmonary disease, congestive heart failure, valvular heart
disease

- Subjects with (World Health Organization (WHO) functional Class I or Class IV

- Subjects with total lung capacity (TLC) < 60% of predicted

- Subjects with significant obstructive lung disease with FEV1/FVC ratio < 70% of
predicted

- Subjects with hypotension defined as systolic arterial pressure < 90 mmHg at baseline

- Subjects with hypertension defined as systolic arterial pressure >140 mmHg at baseline
and a diastolic arterial pressure > 90 mmHg despite adequate medical therapy.

- Subjects with impaired renal function as defined as estimated glomerular filtration
rate (eGFR) less than 45 mL/min/BSA (where BSA=1.73m2) as calculated by the
Modification of Diet in Renal Disease (MDRD) equation:

Patients with eGFR 45-50 mL/min/BSA may be enrolled only after discussion with data safety
monitoring board. Patients with eGFR = 50 mL/min/BSA may be enrolled without such a
discussion.

- Subjects with liver function tests (transaminases (AST/ALT), total bilirubin, and
alkaline phosphatase) >2X normal values

- Subjects with acutely decompensated heart failure requiring hospitalization or
medication adjustment or hospitalization for any cause within the previous 30 days
prior to screening

- Subjects may not be receiving any other investigational agents

- Subjects with left ventricular ejection fraction <45% or left ventricular shortening
fraction <0.2

- Subjects with acute myocardial infarction within 90 days prior to screening

- Subjects taking nitrates for any medical problem

- Subjects with a recent (<180 days) history of pulmonary embolism verified by
ventilation/perfusion scan, angiogram or spiral CT scan

- Pregnant or lactating women

- Subjects with a history of current drug abuse including alcohol

- History of gastric bypass surgery

- History of sinus or atrioventricular nodal disease ie. sick sinus syndrome, or second
or third degree heart block.



Age minimum: 18 Years
Age maximum: 72 Years
Gender: All
Health Condition(s) or Problem(s) studied
Pulmonary Arterial Hypertension
Intervention(s)
Drug: Placebo
Drug: Ranolazine
Primary Outcome(s)
Change in pulmonary vascular resistance (PVR) [Time Frame: 12 weeks]
Secondary Outcome(s)
Change in 6MWD [Time Frame: 12 weeks]
Change in CPET (VE/VCO2, PETCO2, peak VO2, peak HR, peak RER, work max (MET or Watt), sub maximum exercise time [Time Frame: 12 weeks]
Change in RV echo parameters: 2D, 3D [Time Frame: 12 weeks]
Safety/SAE [Time Frame: 12 weeks]
Secondary ID(s)
11-0301
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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