Clincosm LogoSign in Get a demo

Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension

Sponsor
Hanmi Pharmaceutical Company Limited (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01913847
Collaborator
(none)
144
Enrollment
1
Location
2
Arms
63
Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Phase III Study to Evaluate Efficacy and Safety of HGP1207 in Patients With Pulmonary Hypertension Associated With Systolic Heart Failure
Study Start Date :
Sep 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sildenafil

Sildenafil 20 mg

Drug: Sildenafil
Oral sildenafil 20 mg TID for 12 weeks
Other Names:
  • HGP1207
  • PAHTENSION chewable tablet

    		•
    Placebo Comparator: Placebo

    Placebo

    Drug: Placebo
    Oral placebo TID for 12 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in 6-min-walk test distance [at 12 weeks]

    Secondary Outcome Measures

    1. Change from baseline in 6-min-walk test distance [at 6 weeks]

    2. Change from baseline in systolic pulmonary arterial pressure (PAP) [at 6 weeks and 12 weeks]

    3. Change from baseline in [NT pro-BNP] [at 6 weeks and 12 weeks]

    4. Improvement in NYHA functional class [at 6 weeks and 12 weeks]

    5. Quality of life (QoL) assessed by EuroQoL(EQ-5D-3L) and EQ visual analogue scales (VAS) [at 6 weeks and 12 weeks]

    6. Delaying time to first occurrence of either cardiovascular events [12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 11 institutions including Hallym University Dongtan Sacred Heart Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Hanmi Pharmaceutical Company Limited

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hanmi Pharmaceutical Company Limited
    ClinicalTrials.gov Identifier:
    NCT01913847
    Other Study ID Numbers:
    • HM-SIL-301
    First Posted:
    Aug 1, 2013
    Last Update Posted:
    Nov 27, 2017
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Hypertension, Pulmonary
    Hypertension
    Systolic Murmurs
    Sildenafil Citrate

    Study Results

    No Results Posted as of Nov 27, 2017