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Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01913847
Recruitment Status : Unknown
Verified November 2017 by Hanmi Pharmaceutical Company Limited.
Recruitment status was:  Recruiting
First Posted : August 1, 2013
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Study Description
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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
Pulmonary Hypertension Systolic Dysfunction Drug: Sildenafil Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Change from baseline in 6-min-walk test distance [ Time Frame: at 12 weeks ]

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

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01913847


Contacts
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Contact: Bae monobhy@hanmi.co.kr

Locations
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Korea, Republic of
11 institutions including Hallym University Dongtan Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ok    82-31-8086-2538    sokei@hanmail.net   
Principal Investigator: Kyu Hyung Ryu, M.D. Ph.D.         
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
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Principal Investigator: Kyu Hyung Ryu, M.D. Ph.D. Hallym University Dongtan Sacred Heart Hospital
More Information
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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01913847    
Other Study ID Numbers: HM-SIL-301
First Posted: August 1, 2013    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Systolic Murmurs
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heart Murmurs
 Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents