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A Randomized Trial of Udenafil Therapy in Patients With Heart Failure With Preserved Ejection Fraction [ULTIMATE-HFpEF]

NCT01599117 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2013-01-31

No results posted yet for this study

Summary

The investigators hypothesized that udenafil, a newly developed phosphodiesterase type 5 inhibitor, would improve symptom, exercise capacity and hemodynamic status in patients with heart failure with preserved ejection fraction (HFpEF).

Conditions

  • Diastolic Heart Failure

Interventions

DRUG

Placebo

Capsule, appears identical with udenafil, will be provided by Dong-A pharmaceutical company. Patients will receive 50 mg of placebo drug two times a day for 4 weeks, and then the dosage will be escalated to 100 mg two times a day for next 8 weeks.

DRUG

Udenafil (Zydena)

Udenafil (Zydena), a newly developed PDE-5 inhibitor by Dong-A pharmaceutical company, will be administered to patients in this group, 50 mg two times a day for 4 weeks, and then the dosage will be escalated to 100 mg two times a day for next 8 weeks.

Sponsors & Collaborators

  • Dong-A Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Seoul National University Bundang Hospital

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Yong-Jin Kim, MD, PhD · Seoul National University Hospital

  • In-Chang Hwang, MD · Seoul National University Hospital

  • Goo-Yeong Cho, MD, PhD · Seoul National University Bundang Hospital

  • Hyung-Kwan Kim, MD, PhD · Seoul National University Hospital

  • Seung-Pyo Lee, MD · Seoul National University Hospital

  • Kyung-Hee Kim, MD · Seoul National University Hospital

  • Yeonyee E Yoon, MD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-04-30
Completion
2013-05-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01599117 on ClinicalTrials.gov