Study of Safety, Tolerability and Pharmacokinetics of Serelaxin in Japanese Acute Heart Failure (AHF) Patients

NCT ID: NCT02002702

Last Updated: 2015-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-08-31

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled study to assess safety, tolerability and pharmacokinetics and to explore efficacy of IV infusion of 10 µg/kg/day and 30 µg/kg/day serelaxin for 48 hours compared to placebo, when added to the standard therapy, in approximately 45 Japanese AHF patients.

Conditions

Acute Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Serelaxin 10 mcg/kg/Day

Participants received 10 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.

Group Type: EXPERIMENTAL

Serelaxin

Intervention Type: DRUG

Intravenous infusion

Serelaxin 30 mcg/kg/Day

Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.

Group Type: EXPERIMENTAL

Serelaxin

Intervention Type: DRUG

Intravenous infusion

Placebo

Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Serelaxin

Intravenous infusion

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Written informed consent must be obtained before any study-specific assessment is performed.
• Male or female ≥20 years of age, with body weight ≥30 kg and ≤160 kg
• Hospitalized for AHF; AHF is defined as including all of the followings measured at any time between presentation (including the emergency department) and the end of screening:
• Dyspnea at rest or with minimal exertion
• Pulmonary congestion on chest radiograph
• BNP ≥350 pg/mL or NT-proBNP ≥1,400 pg/mL
• SBP ≥125 mmHg at the start and at the end of screening
• Able to be randomized within 16 hours from presentation to the hospital, including the emergency department
• Received intravenous (IV) furosemide of at least 40 mg (or equivalent) at any time between presentation (this include outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute heart failure (HF) episode.
• Impaired renal function defined as an estimated glomerular filtration rate (eGFR) between presentation and randomization of ≥ 25 and≤ 75 mL/min/1.73 m2, calculated using the Japanese formula

Exclusion Criteria

• Dyspnea primarily due to non-cardiac causes
• Temperature >38.5°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment
• Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.
• AHF due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate <45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of >130 beats per minute.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Seto, Aichi-ken, Japan

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Novartis Investigative Site

Iizuka, Fukuoka, Japan

Novartis Investigative Site

Hiroshima, Hiroshima, Japan

Novartis Investigative Site

Amagasaki, Hyōgo, Japan

Novartis Investigative Site

Higashiibaraki-gun, Ibaraki, Japan

Novartis Investigative Site

Kanazawa, Ishikawa-ken, Japan

Novartis Investigative Site

Kawasaki, Kanagawa, Japan

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Novartis Investigative Site

Sendai, Miyagi, Japan

Novartis Investigative Site

Ueda, Nagano, Japan

Novartis Investigative Site

Osaka, Osaka, Japan

Novartis Investigative Site

Sayama, Saitama, Japan

Novartis Investigative Site

Komatsushimachō, Tokushima, Japan

Novartis Investigative Site

Itabashi-ku, Tokyo, Japan

Countries

Japan

Other Identifiers

CRLX030A1201

Identifier Type: -

Identifier Source: org_study_id