Who is sponsoring PRONTO?

PRONTO is sponsored by The Medicines Company.

What condition does PRONTO study?

PRONTO studies Hypertension, Heart Failure.

What drugs are being tested in PRONTO?

Interventions: Clevidipine, Standard of Care IV antihypertensive.

Last reviewed 2014-08-21 · How we verify

A Safety and Efficacy Study of Blood Pressure Control in Acute Heart Failure - A Pilot Study (PRONTO)

NCT00803634 Phase 3 COMPLETED Results posted

The purpose of this study was to evaluate the efficacy and safety of intravenous (IV) clevidipine as compared with standard of care IV antihypertensive agents for blood pressure (BP) lowering in patients with acute heart failure and elevated BP.

Details

Lead sponsor	The Medicines Company
Phase	Phase 3
Status	COMPLETED
Enrolment	117
Start date	2008-12
Completion	2012-03

Conditions

Hypertension
Heart Failure

Interventions

Clevidipine
Standard of Care IV antihypertensive

Primary outcomes

Time to First Achieve Initial Prespecified SBP Target Range and 15% Reduction From Baseline Within First 30 Minutes — Initiation of study drug through the initial 30-minutes
Time to first achieve the initial pre-specified systolic blood pressure (SBP) target range and a 15% SBP reduction from baseline is the time in minutes between the initiation of study medication and the time the patient first achieved both components. Median time was estimated using Kaplan Meier method. 95% two-sided confidence interval of the median time is from 'Simon and Lee, 1982'. If patients did not reach both components within 30 minutes from the initial treatment with study medication, or another antihypertensive agent was administered, the patient was censored at 30 minutes or the time when another antihypertensive agent is given, whichever came first.
Percentage to First Achieve Initial Prespecified SBP Target Range [≥20 mm Hg and ≤40 mm Hg Apart] and 15% Reduction From Baseline Within First 30 Minutes — Initiation of study drug through the initial 30-minutes
Analysis of the percentage of patients achieving both components of this composite endpoint (attainment of the initial prespecified SBP target range and a 15% reduction in SBP from baseline) was calculated within each treatment group using the number of mITT patients achieving the SBP reduction goal divided by the number of mITT patients, and multiplied by 100.

Countries

United States, France, Germany