Pulmonary HypertensionPhase 3NCT01913847
Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension
A Phase 3 study testing Sildenafil in people with Pulmonary Hypertension and Systolic Dysfunction, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pulmonary Hypertension, Systolic Dysfunction
- What is being tested?
- Sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Bae contact
South Korea1 site, 1 recruiting
- Recruiting
11 institutions including Hallym University Dongtan Sacred Heart Hospital
Seoul
Ok, 82-31-8086-2538, sokei@hanmail.net
Kyu Hyung Ryu, M.D. Ph.D.
About this study
Official title: 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.
- Conditions
- Pulmonary Hypertension, Systolic Dysfunction
- Being tested
- Sildenafil, Placebo
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Also called HGP1207, PAHTENSION chewable tablet
Oral sildenafil 20 mg TID for 12 weeks
PlaceboDrug
Oral placebo TID for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil | Experimental | Sildenafil 20 mg Receives: Drug: Sildenafil |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in 6-min-walk test distance
Measured: at 12 weeks
Secondary outcomes (6)
Change from baseline in 6-min-walk test distance
Measured: at 6 weeks
Change from baseline in systolic pulmonary arterial pressure (PAP)
Measured: at 6 weeks and 12 weeks
Change from baseline in [NT pro-BNP]
Measured: at 6 weeks and 12 weeks
Improvement in NYHA functional class
Measured: at 6 weeks and 12 weeks
Quality of life (QoL) assessed by EuroQoL(EQ-5D-3L) and EQ visual analogue scales (VAS)
Measured: at 6 weeks and 12 weeks
Delaying time to first occurrence of either cardiovascular events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyu Hyung Ryu, M.D. Ph.D., Principal investigator, Hallym University Dongtan Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913847
- Sponsor's protocol ID
- HM-SIL-301
- Status last verified
- Nov 2017
- First submitted
- 30 Jul 2013
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study to Evaluate Efficacy and Safety of HGP1207 in Patients With Pulmonary Hypertension Associated With Systolic Heart Failure
- ClinicalTrials.gov ID
- NCT01913847
- Acronym / sponsor ID
- HM-SIL-301
- Conditions
- Pulmonary Hypertension, Systolic Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 1 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil | Experimental | Drug: SildenafilSildenafil 20 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SildenafilAlso: HGP1207, PAHTENSION chewable tabletOral sildenafil 20 mg TID for 12 weeks | Drug | Sildenafil |
| PlaceboOral placebo TID for 12 weeks | Drug | Placebo |
Primary outcome
Change from baseline in 6-min-walk test distance
Time frame: at 12 weeks
6 secondary outcomes
Change from baseline in 6-min-walk test distance
Time frame: at 6 weeks
Change from baseline in systolic pulmonary arterial pressure (PAP)
Time frame: at 6 weeks and 12 weeks
Change from baseline in [NT pro-BNP]
Time frame: at 6 weeks and 12 weeks
Improvement in NYHA functional class
Time frame: 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
Delaying time to first occurrence of either cardiovascular events
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bae contact
Kyu Hyung Ryu, M.D. Ph.D. principal investigator
Hallym University Dongtan Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sildenafil in people with Pulmonary Hypertension and Systolic Dysfunction, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bae (monobhy@hanmi.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in 6-min-walk test distance (time frame: at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2017.