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Spinach soup, Asparagus soup

Phase 2

Healthy | Unknown | Other |Unity Biotechnology, Inc.|Last Updated: Mar 10, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment31
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01604993Acute Effect of Nitrate From Natural Dietary Sources on Arterial Stiffness and Blood Pressures in Healthy IndividualsPHASE2 COMPLETED 31 — — Oct 1, 2011Oct 1, 2013Mar 10, 20141 Canada
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Study Endpoints
Primary Endpoints
Aortic augmentation index (arterial stiffness)
At each treatment visits, this measurement will be taken in at baseline, 1, 2, and 3 hours post-treatment.
Secondary Endpoints
Peripheral (brachial) and central (aortic) systolic and diastolic blood pressure
Brachial blood pressure will be measured at 0 , 1, 2, and 3 hours post -treatmentbaseline and at 1, 2 and 3 hours at every visit.
Subendocardial viability ratio (SEVR)
At 1 hours intervals starting from baseline and ending at 3 hours.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeHEALTH_SERVICES_RESEARCH
Treatment Arms
ArmTypeDescription
High nitrate dietary sourceEXPERIMENTAL556 grams of high nitrate spinach soup that is orally consumed as a single dose for 7 days.
No Nitrate dietary sourcePLACEBO_COMPARATOR556g low nitrate asparagus soup; orally consumed as a single does for 7 days.
Interventions
NameTypeDescription
Spinach soupOTHER556 g of high Nitrate spinach soup that is orally consumed as a single dose for 7 days
Asparagus soupOTHER556 grams of low nitrate asparagus soup that is orally consumed for a period of 7 days as a single does
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy volunteers aged 18-50 * Must consider themselves to be in good overall health and be free of any conditions or illnesses Women must be post-menopausal or not pregnant. * Body mass index (BMI) must be \<30kg/m\^2. * Normotensive, as defined by brachial SBP \<140mmHg and...

Countries:Canada
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