Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension

November 24, 2017 updated by: Hanmi Pharmaceutical Company Limited

Phase III Study to Evaluate Efficacy and Safety of HGP1207 in Patients With Pulmonary Hypertension Associated With Systolic Heart Failure

The purpose of this study is to investigate the safety and clinical efficacy of HGP1207 (Sildenafil) in subjects with pulmonary hypertension associated with systolic heart failure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • 11 institutions including Hallym University Dongtan Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Kyu Hyung Ryu, M.D. Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a diagnosis of chronic heart failure (NYHA Class II and III)
  • LVEF ≤ 40%
  • Elevated systolic PAP: ≥ 40 mmHg
  • Patients must be treated with an ACE inhibitor, ARB, beta-blocker, aldosterone antagonist at a stable dose for at least 4 weeks prior to visit 1

Exclusion Criteria:

  • Patients with pulmonary hypertension associated with chronic obstructive pulmonary disease, interstitial lung disease, chronic thromboembolism or unclear/multifactorial mechanisms
  • Patients who have received Nitrates/NO donor or Cytochrome P450 3A4 inhibitors within 30 days prior to visit 1
  • Patients who have received calcium channel blocker, endothelin receptor antagonist, prostacyclin analogues, phosphodiesterase 5 inhibitors within 90 days prior to visit 1
  • History of hypersensitivity or allergy to sildenafil or any excipients of its formulation
  • Patients with hypertension (sitSBP >170 mmHg or sitDBP>100 mmHg) or hypotension (sitSBP<90 mmHg or sitDBP<50 mmHg)
  • Patients with other medical condition (i.e.,alcoholism, drug abuse) that may cause the patient to be non-compliant with the protocol, confound the data interpretation
  • Pregnant females or those of child bearing potential who have not had a negative pregnancy test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Oral placebo TID for 12 weeks
Experimental: Sildenafil
Sildenafil 20 mg
Drug: Sildenafil
Oral sildenafil 20 mg TID for 12 weeks
Other Names:
  • HGP1207
  • PAHTENSION chewable tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in 6-min-walk test distance
Time Frame: at 12 weeks
at 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in 6-min-walk test distance
Time Frame: at 6 weeks
at 6 weeks
Change from baseline in systolic pulmonary arterial pressure (PAP)
Time Frame: at 6 weeks and 12 weeks
at 6 weeks and 12 weeks
Change from baseline in [NT pro-BNP]
Time Frame: at 6 weeks and 12 weeks
at 6 weeks and 12 weeks
Improvement in NYHA functional class
Time Frame: at 6 weeks and 12 weeks
at 6 weeks and 12 weeks
Quality of life (QoL) assessed by EuroQoL(EQ-5D-3L) and EQ visual analogue scales (VAS)
Time Frame: at 6 weeks and 12 weeks
at 6 weeks and 12 weeks
Delaying time to first occurrence of either cardiovascular events
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: Kyu Hyung Ryu, M.D. Ph.D., Hallym University Dongtan Sacred Heart Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

July 30, 2013

First Submitted That Met QC Criteria

July 31, 2013

First Posted (Estimate)

August 1, 2013

Study Record Updates

Last Update Posted (Actual)

November 27, 2017

Last Update Submitted That Met QC Criteria

November 24, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-SIL-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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