Pulmonary Arterial HypertensionPhase 3IMPRES ExtnNCT01117987

Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)

A Phase 3 study testing Imatinib in people with Pulmonary Arterial Hypertension, run by Novartis Pharmaceuticals at 59 sites in 13 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a multinational, multi center extension study. This study will provide data on the long-term safety, tolerability, and efficacy of imatinib in the treatment of severe pulmonary arterial hypertension. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Arterial Hypertension
What is being tested?: Imatinib
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: 59 sitesin 13 countries
Study dates: Apr 2010to Apr 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who participated in CQTI571A2301 clinical trial and completed the week 24 visit of the study protocol, including all Study Completion assessments
Patients who withdrew from the CQTI571A2301 study prematurely for reasons not related to study drug or not related to a safety issue but performed all Study Completion assessments

Who cannot join

Patients with a pulmonary capillary wedge pressure > 15 mmHg at time of Study Completion assessments in core protocol CQTI571A2301. If pulmonary capillary wedge pressure is not attainable, then a left atrial pressure measurement may be used in its place.
LVEF < 45%
Patients with thrombocytopenia, platelet count < 50E9/L (50E3/µL)
Patients with uncontrolled systemic arterial hypertension, systolic > 160 mmHg or diastolic > 90 mmHg
Patients with a QTcF > 450 ms for males and > 470 ms for females in the absence of right branch bundle block (based on Visit 1 ECG if required to be performed)
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

59 sites in 13 countries.

Country

City, postcode or hospital

59 sites in 13 countries

United States19 sites

Novartis Investigative Site
Birmingham, Alabama, 35294-0006
Novartis Investigative Site
Chicago, Illinois, 60637
Novartis Investigative Site
Cincinnati, Ohio, 45219
Novartis Investigative Site
Cleveland, Ohio, 44195
Novartis Investigative Site
Durham, North Carolina, 27710
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Los Angeles, California, 90095
Novartis Investigative Site
Milwaulkee, Wisconsin, 53215
Novartis Investigative Site
Mineola, New York, 11501
Novartis Investigative Site
New York, New York, 10029
Novartis Investigative Site
Oklahoma City, Oklahoma, 73104
Novartis Investigative Site
Omaha, Nebraska, 68131
Novartis Investigative Site
Phoenix, Arizona, 85013
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15213
Novartis Investigative Site
Rochester, Minnesota, 55905
Novartis Investigative Site
San Francisco, California, 94143
Novartis Investigative Site
St Louis, Missouri, 63110
Novartis Investigative Site
Tualatin, Oregon, 97062
Novartis Investigative Site
Weston, Florida, 33331

Other trials in United States

Germany12 sites

Novartis Investigative Site
Berlin, 12552
Novartis Investigative Site
Berlin, 12683
Novartis Investigative Site
Cologne, 50937
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Homburg, 66421
Novartis Investigative Site
Marburg, 35039
Novartis Investigative Site
München, 81377
Novartis Investigative Site
Regensburg, 93053
Novartis Investigative Site
Würzburg, 97080

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Spain6 sites

Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Madrid, Madrid, 28041
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Santander, Cantabria, 39008
Novartis Investigative Site
Seville, Andalusia, 41013

Other trials in Spain

Japan5 sites

Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-8655
Novartis Investigative Site
Hamamatsu, Shizuoka, 431-3192
Novartis Investigative Site
Mitaka, Tokyo, 181-8611
Novartis Investigative Site
Okayama, Okayama-ken, 701-1192
Novartis Investigative Site
Sendai, Miyagi, 980-8574

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United Kingdom4 sites

Novartis Investigative Site
Cambridge, Cambridgeshire, CB23 3RE
Novartis Investigative Site
London, NW3 3QG
Novartis Investigative Site
Newcastle upon Tyne, Newcastle, NE7 7DN
Novartis Investigative Site
Sheffield, South Yorkshire, S10 2JF

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Canada3 sites

Novartis Investigative Site
Calgary, Alberta, T1Y 6J4
Novartis Investigative Site
Edmonton, Alberta, T6G 2B7
Novartis Investigative Site
London, Ontario, N6A 4G5

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South Korea3 sites

Novartis Investigative Site
Seoul, Korea, 110 744
Novartis Investigative Site
Seoul, Korea, 120-752
Novartis Investigative Site
Seoul, Korea, 135-710

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Italy2 sites

Novartis Investigative Site
Pavia, (pv), 27100
Novartis Investigative Site
Roma, RM, 00161

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Austria1 site

Novartis Investigative Site
Vienna, A-1090

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Belgium1 site

Novartis Investigative Site
Leuven, 3000

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France1 site

Novartis Investigative Site
Clamart, 92141

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Netherlands1 site

Novartis Investigative Site
Amsterdam, 1081 HV

Other trials in Netherlands

Switzerland1 site

Novartis Investigative Site
Sankt Gallen, 9007

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About this study

Official title: An Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Oral QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension: IMPRES Extension

Conditions: Pulmonary Arterial Hypertension
Being tested: Imatinib, Placebo
Keywords: Pulmonary arterial hypertension, imatinib, 6MWD, pulmonary hypertension
Medical subject headings: Pulmonary Arterial Hypertension, Hypertension, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ImatinibDrug
Participants, who received imatinib 200 mg in the core study, CQTI571A2301 (NCT00902174), and completed the core study, received imatinib 200 mg every day (qd) in the extension. Participants, who were randomized to receive imatinib 400 mg in the core study and completed the core study, received imatinib 400 mg qd in the extension. Participants, who terminated early from the core study or who were randomized to placebo and completed the core study, started the extension with imatinib 200 mg qd. After 2 weeks, the dose was increased to 400 mg qd if tolerated.
PlaceboDrug
To preserve the blind of the core study until the core study, CQTI571A2301 (NCT00902174), was completed, participants received a blinded study drug package containing a 70-tablet bottle of imatinib and a 70-tablet bottle of matching placebo.

Study groups in NCT01117987
Study group	Role	What they receive
Core imatinib	Experimental	Depending on the participants' randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated. Receives: Drug: Imatinib; Drug: Placebo
Core placebo	Experimental	Depending on the participants' randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated. Receives: Drug: Imatinib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Adverse event monitoring was conducted throughout the study.
Measured: 204 weeks

Secondary outcomes (2)

Change From Core Study Baseline in Six-Minute Walk Distance (6MWD)
A six minute walk test (6MWT) was performed in accordance with the guidleines of the American Thoracic Society (2002).
Measured: core study baseline, extension baseline, 12 weeks, 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 156 weeks, 204 weeks
Percentage of Participants With Incidence of Clinical Worsening Events
Clinical worsening events included death, overnight hospitalization for worsening of PAH, worsening of World Health Organization (WHO) functional class by at least one level (drop in WHO ), 15% decrease in the 6MWD as compared to baseline confirmed by two 6MWTs at two consecutive study visits (6MWD reduction), and drop in WHO \& 6MWD reduction. Some participants have fulfilled more than one criterion. Therefore, the sum of individual components may be higher than the total number of participants with clinical worsening.
Measured: 204 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Apr 2014

First posted6 May 2010 (estimated)
Study startApr 2010
Primary completionApr 2014
Study completionApr 2014

Why it stopped: Novartis discontinued the development of imatinib in PAH due to requirement of regulatory authorities for additional data to secure marketing approval in PAH.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01117987
Sponsor's protocol ID: CQTI571A2301E1
Other IDs: 2009-018167-26, 2009
Acronym: IMPRES Extn
Status last verified: Jul 2015
First submitted: 3 May 2010
Last updated: 13 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Arterial Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Oral QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension: IMPRES Extension
ClinicalTrials.gov ID: NCT01117987
Acronym / sponsor ID: IMPRES Extn / CQTI571A2301E1
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary arterial hypertension, imatinib, 6MWD, pulmonary hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Novartis discontinued the development of imatinib in PAH due to requirement of regulatory authorities for additional data to secure marketing approval in PAH.
Enrolment: 144 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 6 May 2010 (estimated)
Results: Posted 21 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Core imatinib	Experimental	Drug: Imatinib, Drug: PlaceboDepending on the participants' randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
Core placebo	Experimental	Drug: Imatinib, Drug: PlaceboDepending on the participants' randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients who participated in CQTI571A2301 clinical trial and completed the week 24 visit of the study protocol, including all Study Completion assessments
Patients who withdrew from the CQTI571A2301 study prematurely for reasons not related to study drug or not related to a safety issue but performed all Study Completion assessments

Key exclusion criteria (6 listed)

Patients with a pulmonary capillary wedge pressure > 15 mmHg at time of Study Completion assessments in core protocol CQTI571A2301. If pulmonary capillary wedge pressure is not attainable, then a left atrial pressure measurement may be used in its place.
LVEF < 45%
Patients with thrombocytopenia, platelet count < 50E9/L (50E3/µL)
Patients with uncontrolled systemic arterial hypertension, systolic > 160 mmHg or diastolic > 90 mmHg
Patients with a QTcF > 450 ms for males and > 470 ms for females in the absence of right branch bundle block (based on Visit 1 ECG if required to be performed)

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
ImatinibParticipants, who received imatinib 200 mg in the core study, CQTI571A2301 (NCT00902174), and completed the core study, received imatinib 200 mg every day (qd) in the extension. Participants, who were randomized to receive imatinib 400 mg in the core study and completed the core study, received imatinib 400 mg qd in the extension. Participants, who terminated early from the core study or who were randomized to placebo and completed the core study, started the extension with imatinib 200 mg qd. After 2 weeks, the dose was increased to 400 mg qd if tolerated.	Drug	Core imatinib, Core placebo
PlaceboTo preserve the blind of the core study until the core study, CQTI571A2301 (NCT00902174), was completed, participants received a blinded study drug package containing a 70-tablet bottle of imatinib and a 70-tablet bottle of matching placebo.	Drug	Core imatinib, Core placebo

Primary outcome

Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Time frame: 204 weeks
Adverse event monitoring was conducted throughout the study.

2 secondary outcomes

Change From Core Study Baseline in Six-Minute Walk Distance (6MWD)
Time frame: core study baseline, extension baseline, 12 weeks, 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 156 weeks, 204 weeks
Percentage of Participants With Incidence of Clinical Worsening Events
Time frame: 204 weeks

Results and safety

Results posted to the registry on 21 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Core Imatinib	66	5
Core Placebo	78	4

Primary outcome: Number of Participants With Adverse Events, Serious Adverse Events and Deaths

Time frame: 204 weeks. Number. Unit: Participants

Measure	Core Imatinib n = 66	Core Placebo n = 78
Adverse events (non-serious and serious)	62	76
Serious adverse events	40	53
Deaths	6	10

Population analysed: Safety analysis set: The safety set included all paticipants who received at least one dose of study drug during the extension.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Core Imatinib	40 of 66 (60.6%)	55 of 66 (83.3%)	Not reported
Core Placebo	53 of 78 (67.9%)	72 of 78 (92.3%)	Not reported

Limitations and caveats (from the sponsor): Within primary outcome measure (OM) #1, an additional death (\>30 days post study completion) was included in the imatinib arm. The participant flow and secondary OM #2 reflect deaths that occurred up to and including 30 days post study completion.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Active, not recruitingPhase 1
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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.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

59 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Imatinib in people with Pulmonary Arterial Hypertension, run by Novartis Pharmaceuticals at 59 sites in 13 countries.

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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Germany, Spain, Japan, United Kingdom and 8 more countries. 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. 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?

Yes. Results are posted in the registry (first posted 21 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events, Serious Adverse Events and Deaths (time frame: 204 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01117987.

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 13 Aug 2015.