Back to results

Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension

Primary Purpose

Pulmonary Hypertension, Systolic Dysfunction

Status

Unknown status

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Sildenafil

Placebo

About this trial

This is an interventional treatment trial for Pulmonary Hypertension

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

11 institutions including Hallym University Dongtan Sacred Heart HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sildenafil

Placebo

Arm Description

Sildenafil 20 mg

Placebo

Outcomes

Primary Outcome Measures

Change from baseline in 6-min-walk test distance

Secondary Outcome Measures

Change from baseline in 6-min-walk test distance

Change from baseline in systolic pulmonary arterial pressure (PAP)

Change from baseline in [NT pro-BNP]

Improvement in NYHA functional class

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

Delaying time to first occurrence of either cardiovascular events

Full Information

NCT ID

NCT01913847

First Posted

July 30, 2013

Last Updated

November 24, 2017

Sponsor

Hanmi Pharmaceutical Company Limited

1. Study Identification

Unique Protocol Identification Number

NCT01913847

Brief Title

Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Unknown status

Study Start Date

September 2013 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hanmi Pharmaceutical Company Limited

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Hypertension, Systolic Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sildenafil

Arm Type

Experimental

Arm Description

Sildenafil 20 mg

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Sildenafil

Other Intervention Name(s)

HGP1207, PAHTENSION chewable tablet

Intervention Description

Oral sildenafil 20 mg TID for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral placebo TID for 12 weeks

Primary Outcome Measure Information:

Title

Change from baseline in 6-min-walk test distance

Time Frame

at 12 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in 6-min-walk test distance

Time Frame

at 6 weeks

Title

Change from baseline in systolic pulmonary arterial pressure (PAP)

Time Frame

at 6 weeks and 12 weeks

Title

Change from baseline in [NT pro-BNP]

Time Frame

at 6 weeks and 12 weeks

Title

Improvement in NYHA functional class

Time Frame

at 6 weeks and 12 weeks

Title

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

Time Frame

at 6 weeks and 12 weeks

Title

Delaying time to first occurrence of either cardiovascular events

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bae

monobhy@hanmi.co.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kyu Hyung Ryu, M.D. Ph.D.

Organizational Affiliation

Hallym University Dongtan Sacred Heart Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

11 institutions including Hallym University Dongtan Sacred Heart Hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Phone

82-31-8086-2538

sokei@hanmail.net

First Name & Middle Initial & Last Name & Degree

Kyu Hyung Ryu, M.D. Ph.D.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension

We'll reach out to this number within 24 hrs