Pulmonary Arterial HypertensionPhase 3IMPRESNCT00902174
Imatinib (QTI571) in Pulmonary Arterial Hypertension
A Phase 3 study testing imatinib mesylate in people with Pulmonary Arterial Hypertension, run by Novartis Pharmaceuticals at 95 sites in 14 countries.
Trial summary
A multinational, multicenter, double blind, placebo-controlled study evaluating the efficacy and safety of imatinib as an add-on therapy in the treatment of patients with severe pulmonary arterial hypertension (PAH). 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 mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 95 sitesin 14 countries
- Study dates
- Sep 2009to May 2011
- 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
- Male or female patients ≥18 years of age with a current diagnosis of pulmonary arterial hypertension (PAH) according to the Dana Point 2008 Meeting: World Health Organization (WHO) Diagnostic Group I, idiopathic or heritable (familial or sporadic) PAH, PAH associated with collagen vascular disease including systemic sclerosis, rheumatoid arthritis, mixed connective tissue diseases, and overlap syndrome. PAH following one year repair of congenital heart defect [Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) or Posterior Descending Artery (PDA)], or PAH associated with diet therapies or other drugs
- A Pulmonary Vascular Resistance (PVR) ≥ 800 dynes.sec.cm-5 (as assessed by Right Heart Catheterization (RHC) at screening or in the 3 months preceding the screening visit) despite treatment with two or more specific PAH therapies, including Endothelin Receptor Antagonists (ERAs), phosphodiesterase 5 inhibitors (PDE5), or subcutaneous, inhaled, intravenous or oral prostacyclin analogues for ≥ 3 months. Background therapy doses were to be stable for ≥ 30 days except for warfarin and prostacyclin analogues ( ≥ 30 days but doses could vary even within the month before enrollment).
- World Health Organization functional Class II-IV. For WHO Functional Class IV, one of the 2 or more specific PAH therapies were to be an inhaled, subcutaneous, intravenous or oral prostacyclin analogue, unless the subject showed intolerance of prostacyclin analogues.
- 6MWD ≥ 150 meters and ≤ 450 meters at screening. Distances of two consecutive 6MWTs were to be within 15% of one another.
Who cannot join
- With a pulmonary capillary wedge pressure > 15 mm Hg to rule out PAH secondary to left ventricular dysfunction.
- With a diagnosis of pulmonary artery or vein stenosis
- Left ventricular ejection fraction (LVEF) < 45%
- With Disseminated Intravascular Coagulation (DIC)
- With evidence of major bleeding or intracranial hemorrhage
- With a history of elevated intracranial pressure
Show all 12Show fewer
- With a history of latent bleeding risk such as diabetic retinopathy, gastrointestinal bleeding due to gastric or duodenal ulcers, or colitis ulcerosa
- With a QTcF > 450 msec for males and > 470 msec for females at screening and baseline in the absence of right bundle branch block.
- With a history of ventricular tachycardia, ventricular fibrillation or ventricular flutter
- With a history of Torsades de Pointes
- With a history of long QT syndrome
- Having undergone atrial septostomy in the 3 months prior to the screening visit
Trial locations and contacts
95 sites in 14 countries.
95 sites in 14 countries
United States33 sites
Novartis Investigative Site
Atlanta, Georgia, 30342
Novartis Investigative Site
Aurora, Colorado, 80045
Novartis Investigative Site
Baltimore, Maryland, 21205
Novartis Investigative Site
Birmingham, Alabama, 35294
Novartis Investigative Site
Boston, Massachusetts, 02111
Novartis Investigative Site
Boston, Massachusetts, 02114
Novartis Investigative Site
Boston, Massachusetts, 02118
Novartis Investigative Site
Chicago, Illinois, 60637
Novartis Investigative Site
Cincinnati, Ohio, 45219
Novartis Investigative Site
Clearwater, Florida, 33756
Novartis Investigative Site
Cleveland, Ohio, 44106
Novartis Investigative Site
Cleveland, Ohio, 44195
Novartis Investigative Site
Dallas, Texas, 75390
Novartis Investigative Site
Durham, North Carolina, 27710
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Knoxville, Tennessee, 37934
Novartis Investigative Site
Los Angeles, California, 90024
Novartis Investigative Site
Miami Beach, Florida, 33140
Novartis Investigative Site
Milwaukee, Wisconsin, 53215
Novartis Investigative Site
Minneola, New York, 11501-3893
Novartis Investigative Site
New York, New York, 10029
Novartis Investigative Site
New York, New York, 10032
Novartis Investigative Site
Oklahoma City, Oklahoma, 73104
Novartis Investigative Site
Omaha, Nebraska, 68131
Novartis Investigative Site
Philadelphia, Pennsylvania, 19140
Novartis Investigative Site
Phoenix, Arizona, 85013
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15212
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15213
Novartis Investigative Site
Portland, Oregon, 97210
Novartis Investigative Site
Rochester, Minnesota, 55905
Novartis Investigative Site
San Francisco, California, 94143
Novartis Investigative Site
St Louis, Missouri, 63110
Novartis Investigative Site
Weston, Florida, 33331
Germany13 sites
Novartis Investigative Site
Berlin
Novartis Investigative Site
Cologne
Novartis Investigative Site
Dresden
Novartis Investigative Site
Giessen
Novartis Investigative Site
Greifswald
Novartis Investigative Site
Hamburg
Novartis Investigative Site
Hanover
Novartis Investigative Site
Heidelberg
Novartis Investigative Site
Homburg
Novartis investigative site
Löwenstein
Novartis Investigative Site
München
Novartis Investigative Site
Regensberg
Novartis Investigative Site
Würzberg
Spain12 sites
Novartis Investigative Site
A Coruña
Novartis Investigative Site
Barcelona
Novartis Investigative Site
Caceras
Novartis Investigative Site
Las Palmas de Gran Canarias
Novartis Investigative Site
Madrid
Novartis Investigative Site
Málaga
Novartis investigative site
San Cristóbal de La Laguna
Novartis Investigative Site
Santa Cruz de Tenerife
Novartis Investigative Site
Santander
Novartis Investigative Site
Seville
Novartis investigative site
Valencia
Novartis Investigative Site
Valladolid
Canada7 sites
Novartis Investigative Site
Calgary
Novartis Investigative Site
Edmonton
Novartis Investigative Site
London
Novartis Investigative Site
Montreal
Novartis Investigative Site
Ottawa
Novartis investigative site
Toronto
Novartis Investigative Site
Vancouver
Japan6 sites
Novartis Investigative Site
Bunkyō City
Novartis Investigative Site
Hamamatsu
Novartis Investigative Site
Mitaka
Novartis Investigative Site
Okayama
Novartis Investigative Site
Sendai
Novartis Investigative Site
Suita
United Kingdom5 sites
Novartis Investigative Site
Cambridge
Novartis Investigative Site
Clydebank
Novartis Investigative Site
London
Novartis Investigative Site
Newcastle upon Tyne
Novartis Investigative Site
Sheffield
Italy4 sites
Novartis Investigative Site
Bologna
Novartis Investigative Site
Pavia
Novartis Investigative Site
Pisa
Novartis Investigative Site
Roma
Sweden4 sites
Novartis Investigative Site
Lund
Novartis Investigative Site
Stockholm
Novartis Investigative Site
Umeå
Novartis Investigative Site
Uppsala
Switzerland4 sites
University Hospital Basel
Basel
Novartis Investigative Site
Bern
Novartis Investigative Site
Lausanne
Novartis Investigative Site
Sankt Gallen
Austria2 sites
Novartis investigative site
Innsbruck
Novartis Investigative Site
Vienna
Belgium2 sites
Novartis Investigative Site
Brussels
Novartis Investigative Site
Leuven
About this study
Official title: A 24-week Randomized Placebo-controlled, Double-blind Multi-center Clinical Trial Evaluating the Efficacy and Safety of Oral QTI571 as an add-on Therapy in the Treatment of Severe Pulmonary Arterial Hypertension: Imatinib in Pulmonary Arterial Hypertension, a Randomized, Efficacy Study (IMPRES)
A multinational, multicenter, double blind, placebo-controlled study evaluating the efficacy and safety of imatinib as an add-on therapy in the treatment of patients with severe pulmonary arterial hypertension (PAH).
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- imatinib mesylate, Placebo
- Keywords
- Pulmonary arterial hypertension, Imatinib, 6MWD, Borg scale, 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.
imatinib mesylateDrug
Two or 4 imatinib mesylate (QTI571) 100 mg film coated tablets once daily.
PlaceboDrug
Placebo to imatinib 100 mg film coated tablets
| Study group | Role | What they receive |
|---|---|---|
| imatinib mesylate | Experimental | Imatinib mesylate (QTI571) 200 mg once daily for two weeks, increased to 400 mg once daily if well tolerated. If 400 mg dose was not well tolerated, a down titration to 200 mg once daily was permitted. Receives: Drug: imatinib mesylate |
| Placebo | Placebo comparator | Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Six-minute Walk Distance Test (6MWD) Between Imatinib and Placebo at 24 Weeks
This standardized walk course was 30 meters in length. During the walk the participant was connected to a portable pulse oximeter via a finger probe. Participants were instructed to walk at a comfortable speed for as far as they could manage in 6 minutes. The total distance walked (in meters) was recorded. Results were compared between the 2 groups.
Measured: 24 weeks
Secondary outcomes (15)
Clinical Worsening Comparing Imatinib Versus Placebo for Adjudicated Cases
Clinical worsening per participant was measured by the onset of any adjudicated event (all cause mortality; overnight hospitalization for worsening of Pulmonary Arterial Hypertension (PAH); worsening of WHO functional class by one level; 15% decline in Six Minute Walk Distance (6MWD) measured on two consecutive occasions) at 24 weeks treatment, comparing imatinib to placebo groups. A cox regression analysis model was used.
Measured: 24 weeks
Change From Baseline in Right Atrial Pressure
Change from baseline in right atrial pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The right atrial pressure was assessed when the participant was in a stable hemodynamic rest state. A higher right atrial pressure number indicates worsening.
Measured: baseline and week 24
Change From Baseline in Mean Pulmonary Arterial Pressure
Change from baseline in mean pulmonary arterial pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The mean pulmonary arterial pressure was assessed when the participant was in a stable hemodynamic rest state. A higher mean pulmonary arterial pressure number indicates worsening.
Measured: baseline and week 24
Change From Baseline in Mean Pulmonary Capillary Wedge Pressure
Change from baseline in mean pulmonary capillary wedge pressure (mmHg)was measured via right heart catheterization according to the local hospital procedures. The right atrial mean pulmonary capillary wedge pressure was assessed when the participant was in a stable hemodynamic rest state.
Measured: baseline and week 24
Change From Baseline in Systemic Vascular Resistance
Change from baseline in systemic vascular resistance (dynes*sec*cm^-5) was measured via right heart catheterization according to the local hospital procedures. The systemic vascular resistance was assessed when the participant was in a stable hemodynamic rest state. Reduction from baseline in mean systemic vascular resistance indicates improvement.
Measured: baseline and week 24
Change From Baseline in Pulmonary Vascular Resistance
Change from baseline in pulmonary vascular resistance (dynes*sec*cm^-5) was measured via right heart catheterization according to the local hospital procedures. The pulmonary vascular resistance was assessed when the participant was in a stable hemodynamic rest state. Reduction from baseline in pulmonary vascular resistance indicates improvement.
Measured: baseline and week 24
Change From Baseline in Pulmonary Resistance Index
Change from baseline in pulmonary resistance index (dynes*sec*cm^-5/m2) was measured via right heart catheterization according to the local hospital procedures. The pulmonary resistance index was assessed when the participant was in a stable hemodynamic rest state. A reduction from baseline in pulmonary resistance index indicates improvement.
Measured: baseline and week 24
Change From Baseline in Cardiac Output
Change from baseline in cardiac output (L/min) was measured via right heart catheterization according to the local hospital procedures. The cardiac output was assessed when the participant was in a stable hemodynamic rest state. An increase from baseline (higher number) in cardiac output indicates improvement.
Measured: 24 weeks
Change From Baseline in Systolic Arterial Blood Pressure
Change from baseline in systolic arterial blood pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The systolic arterial blood was assessed when the participant was in a stable hemodynamic rest state.
Measured: baseline and week 24
Change From Baseline in Diastolic Arterial Blood Pressure
Change from baseline in diastolic arterial blood pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The diastolic arterial blood pressure was assessed when the participant was in a stable hemodynamic rest state.
Measured: baseline and week 24
Change From Baseline in Heart Rate
Change from baseline in heart rate (bpm) was measured via right heart catheterization according to the local hospital procedures. The heart rate was assessed when the participant was in a stable hemodynamic rest state.
Measured: 24 weeks
Change in Borg Dyspnea Score During 6-minute Walk Test
Change in Borg scale was measured at different time points at week 24. The Borg Scale consists of scale range of 0 to 10. Participants pointed to indicate their level of dyspnea before and at the end of exercise testing (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). A reduction in this score indicates an improvement.
Measured: week 24
Covariance of End of Study CAMPHOR Score
The CAMPHOR test consists of 65 items and 3 scales. Two scales measure Health Related Quality of Life. 1) Symptoms: consists of 25 items measuring loss or abnormality of psychological, physiological or anatomical structure or function; further sub-divided into 3 subscales (energy, breathlessness and mood), 2) Disability: consists of 15 items measuring any restriction or lack of ability to perform an activity. 3) Quality of Life (QOL): consists of 25 items defining how individuals perceived ability and capacity to satisfy their needs. The 25-item symptom and QOL scales score from 0-25 where a higher score indicates the presence of more symptoms and poor QOL, respectively. The 15-item functioning scale scores 0-30; a higher score indicates poor functioning.
Measured: Week 24
Plasma Concentration of QTI571 200 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Blood samples were taken from each subject participating in the study (placebo group and active treatment group) once predose and once between 0 hour to 3 hour post dose at day 1 (baseline), day 14, day 28 and day 168.
The parent compound QTI571 and its active metabolite, GCP74588, were measured in plasma by validated liquid chromatography-mass spectrometry (HPLC-MS/MS) assay.
Measured: predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168
Plasma Concentration of QTI571 400 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Blood samples were taken from each subject participating in the study (placebo group and active treatment group) once predose and once between 0 hour to 3 hour post dose at day 1 (baseline), day 14, day 28 and day 168.
The parent compound QTI571 and its active metabolite, GCP74588, were measured in plasma by validated liquid chromatography-mass spectrometry (HPLC-MS/MS) assay.
Measured: predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2011
- Study completionMay 2011
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.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902174
- Sponsor's protocol ID
- CQTI571A2301
- Acronym
- IMPRES
- Status last verified
- Jun 2013
- First submitted
- 13 May 2009
- Last updated
- 17 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Querejeta Roca G, Campbell P, Claggett B, Solomon SD, Shah AM. Right Atrial Function in Pulmonary Arterial Hypertension. Circ Cardiovasc Imaging. 2015 Nov;8(11):e003521; discussion e003521. doi: 10.1161/CIRCIMAGING.115.003521.
PubMed 26514759Querejeta Roca G, Campbell P, Claggett B, Vazir A, Quinn D, Solomon SD, Shah AM. Impact of lowering pulmonary vascular resistance on right and left ventricular deformation in pulmonary arterial hypertension. Eur J Heart Fail. 2015 Jan;17(1):63-73. doi: 10.1002/ejhf.177. Epub 2014 Nov 4.
PubMed 25367310Shah AM, Campbell P, Rocha GQ, Peacock A, Barst RJ, Quinn D, Solomon SD; IMPRES Investigators. Effect of imatinib as add-on therapy on echocardiographic measures of right ventricular function in patients with significant pulmonary arterial hypertension. Eur Heart J. 2015 Mar 7;36(10):623-32. doi: 10.1093/eurheartj/ehu035. Epub 2014 Feb 23.
PubMed 24566799Hoeper MM, Barst RJ, Bourge RC, Feldman J, Frost AE, Galie N, Gomez-Sanchez MA, Grimminger F, Grunig E, Hassoun PM, Morrell NW, Peacock AJ, Satoh T, Simonneau G, Tapson VF, Torres F, Lawrence D, Quinn DA, Ghofrani HA. Imatinib mesylate as add-on therapy for pulmonary arterial hypertension: results of the randomized IMPRES study. Circulation. 2013 Mar 12;127(10):1128-38. doi: 10.1161/CIRCULATIONAHA.112.000765. Epub 2013 Feb 12.
PubMed 23403476
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week Randomized Placebo-controlled, Double-blind Multi-center Clinical Trial Evaluating the Efficacy and Safety of Oral QTI571 as an add-on Therapy in the Treatment of Severe Pulmonary Arterial Hypertension: Imatinib in Pulmonary Arterial Hypertension, a Randomized, Efficacy Study (IMPRES)
- ClinicalTrials.gov ID
- NCT00902174
- Acronym / sponsor ID
- IMPRES / CQTI571A2301
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Pulmonary arterial hypertension, Imatinib, 6MWD, Borg scale, Pulmonary hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 15 May 2009 (estimated)
- Results
- Posted 16 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multinational, multicenter, double blind, placebo-controlled study evaluating the efficacy and safety of imatinib as an add-on therapy in the treatment of patients with severe pulmonary arterial hypertension (PAH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| imatinib mesylate | Experimental | Drug: imatinib mesylateImatinib mesylate (QTI571) 200 mg once daily for two weeks, increased to 400 mg once daily if well tolerated. If 400 mg dose was not well tolerated, a down titration to 200 mg once daily was permitted. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients ≥18 years of age with a current diagnosis of pulmonary arterial hypertension (PAH) according to the Dana Point 2008 Meeting: World Health Organization (WHO) Diagnostic Group I, idiopathic or heritable (familial or sporadic) PAH, PAH associated with collagen vascular disease including systemic sclerosis, rheumatoid arthritis, mixed connective tissue diseases, and overlap syndrome. PAH following one year repair of congenital heart defect [Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) or Posterior Descending Artery (PDA)], or PAH associated with diet therapies or other drugs
- A Pulmonary Vascular Resistance (PVR) ≥ 800 dynes.sec.cm-5 (as assessed by Right Heart Catheterization (RHC) at screening or in the 3 months preceding the screening visit) despite treatment with two or more specific PAH therapies, including Endothelin Receptor Antagonists (ERAs), phosphodiesterase 5 inhibitors (PDE5), or subcutaneous, inhaled, intravenous or oral prostacyclin analogues for ≥ 3 months. Background therapy doses were to be stable for ≥ 30 days except for warfarin and prostacyclin analogues ( ≥ 30 days but doses could vary even within the month before enrollment).
- World Health Organization functional Class II-IV. For WHO Functional Class IV, one of the 2 or more specific PAH therapies were to be an inhaled, subcutaneous, intravenous or oral prostacyclin analogue, unless the subject showed intolerance of prostacyclin analogues.
- 6MWD ≥ 150 meters and ≤ 450 meters at screening. Distances of two consecutive 6MWTs were to be within 15% of one another.
Key exclusion criteria (12 listed)
- With a pulmonary capillary wedge pressure > 15 mm Hg to rule out PAH secondary to left ventricular dysfunction.
- With a diagnosis of pulmonary artery or vein stenosis
- Left ventricular ejection fraction (LVEF) < 45%
- With Disseminated Intravascular Coagulation (DIC)
- With evidence of major bleeding or intracranial hemorrhage
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 |
|---|---|---|
| imatinib mesylateTwo or 4 imatinib mesylate (QTI571) 100 mg film coated tablets once daily. | Drug | imatinib mesylate |
| PlaceboPlacebo to imatinib 100 mg film coated tablets | Drug | Placebo |
Primary outcome
Difference in Six-minute Walk Distance Test (6MWD) Between Imatinib and Placebo at 24 Weeks
Time frame: 24 weeks
This standardized walk course was 30 meters in length. During the walk the participant was connected to a portable pulse oximeter via a finger probe. Participants were instructed to walk at a comfortable speed for as far as they could manage in 6 minutes. The total distance walked (in meters) was recorded. Results were compared between the 2 groups.
15 secondary outcomes
Clinical Worsening Comparing Imatinib Versus Placebo for Adjudicated Cases
Time frame: 24 weeks
Change From Baseline in Right Atrial Pressure
Time frame: baseline and week 24
Change From Baseline in Mean Pulmonary Arterial Pressure
Time frame: baseline and week 24
Change From Baseline in Mean Pulmonary Capillary Wedge Pressure
Time frame: baseline and week 24
Change From Baseline in Systemic Vascular Resistance
Time frame: baseline and week 24
Change From Baseline in Pulmonary Vascular Resistance
Time frame: baseline and week 24
Change From Baseline in Pulmonary Resistance Index
Time frame: baseline and week 24
Change From Baseline in Cardiac Output
Time frame: 24 weeks
Change From Baseline in Systolic Arterial Blood Pressure
Time frame: baseline and week 24
Change From Baseline in Diastolic Arterial Blood Pressure
Time frame: baseline and week 24
Change From Baseline in Heart Rate
Time frame: 24 weeks
Change in Borg Dyspnea Score During 6-minute Walk Test
Time frame: week 24
Covariance of End of Study CAMPHOR Score
Time frame: Week 24
Plasma Concentration of QTI571 200 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Time frame: predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168
Plasma Concentration of QTI571 400 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Time frame: predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26514759Querejeta Roca G, Campbell P, Claggett B, Solomon SD, Shah AM. Right Atrial Function in Pulmonary Arterial Hypertension. Circ Cardiovasc Imaging. 2015 Nov;8(11):e003521; discussion e003521. doi: 10.1161/CIRCIMAGING.115.003521.
- Derived from this study: PubMed 25367310Querejeta Roca G, Campbell P, Claggett B, Vazir A, Quinn D, Solomon SD, Shah AM. Impact of lowering pulmonary vascular resistance on right and left ventricular deformation in pulmonary arterial hypertension. Eur J Heart Fail. 2015 Jan;17(1):63-73. doi: 10.1002/ejhf.177. Epub 2014 Nov 4.
- Derived from this study: PubMed 24566799Shah AM, Campbell P, Rocha GQ, Peacock A, Barst RJ, Quinn D, Solomon SD; IMPRES Investigators. Effect of imatinib as add-on therapy on echocardiographic measures of right ventricular function in patients with significant pulmonary arterial hypertension. Eur Heart J. 2015 Mar 7;36(10):623-32. doi: 10.1093/eurheartj/ehu035. Epub 2014 Feb 23.
- Derived from this study: PubMed 23403476Hoeper MM, Barst RJ, Bourge RC, Feldman J, Frost AE, Galie N, Gomez-Sanchez MA, Grimminger F, Grunig E, Hassoun PM, Morrell NW, Peacock AJ, Satoh T, Simonneau G, Tapson VF, Torres F, Lawrence D, Quinn DA, Ghofrani HA. Imatinib mesylate as add-on therapy for pulmonary arterial hypertension: results of the randomized IMPRES study. Circulation. 2013 Mar 12;127(10):1128-38. doi: 10.1161/CIRCULATIONAHA.112.000765. Epub 2013 Feb 12.
- Related InfoLink provided by the sponsor.
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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
95 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing imatinib mesylate in people with Pulmonary Arterial Hypertension, run by Novartis Pharmaceuticals at 95 sites in 14 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 95 sites in United States, Germany, Spain, Canada, Japan and 9 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. 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?
Yes. Results are posted in the registry (first posted 16 Jul 2013). 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?
Difference in Six-minute Walk Distance Test (6MWD) Between Imatinib and Placebo at 24 Weeks (time frame: 24 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 NCT00902174, which also lists 4 linked publications.
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 17 Feb 2016.