NCT01913847

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2013

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

5.3 years

First QC Date

July 30, 2013

Last Update Submit

November 24, 2017

Conditions

Pulmonary HypertensionSystolic Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in 6-min-walk test distance

    at 12 weeks

Secondary Outcomes (6)

  • Change from baseline in 6-min-walk test distance

    at 6 weeks

  • Change from baseline in systolic pulmonary arterial pressure (PAP)

    at 6 weeks and 12 weeks

  • Change from baseline in [NT pro-BNP]

    at 6 weeks and 12 weeks

  • Improvement in NYHA functional class

    at 6 weeks and 12 weeks

  • Quality of life (QoL) assessed by EuroQoL(EQ-5D-3L) and EQ visual analogue scales (VAS)

    at 6 weeks and 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Sildenafil

EXPERIMENTAL

Sildenafil 20 mg

Drug: Sildenafil

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

SildenafilDRUG

Oral sildenafil 20 mg TID for 12 weeks

Also known as: HGP1207, PAHTENSION chewable tablet
Sildenafil
PlaceboDRUG

Oral placebo TID for 12 weeks

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

11 institutions including Hallym University Dongtan Sacred Heart Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Kyu Hyung Ryu, M.D. Ph.D.

    Hallym University Dongtan Sacred Heart Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bae

CONTACT

monobhy@hanmi.co.kr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2013

First Posted

August 1, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

November 27, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)