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Imatinib (QTI571) in Pulmonary Arterial Hypertension (IMPRES)

Primary Purpose

Pulmonary Arterial Hypertension

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

imatinib mesylate

Placebo

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Pulmonary arterial hypertension, Imatinib, 6MWD, Borg scale, Pulmonary hypertension

Eligibility Criteria

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

Key Inclusion criteria

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

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
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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

imatinib mesylate

Placebo

Arm Description

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.

Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Plasma Concentration of QTI571 400 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant

Full Information

NCT ID

NCT00902174

First Posted

May 13, 2009

Last Updated

February 16, 2016

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00902174

Brief Title

Imatinib (QTI571) in Pulmonary Arterial Hypertension

Acronym

IMPRES

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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief 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).

6. Conditions and Keywords

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

Pulmonary Arterial Hypertension

Keywords

Pulmonary arterial hypertension, Imatinib, 6MWD, Borg scale, Pulmonary hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

202 (Actual)

8. Arms, Groups, and Interventions

Arm Title

imatinib mesylate

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments.

Intervention Type

Drug

Intervention Name(s)

imatinib mesylate

Intervention Description

Two or 4 imatinib mesylate (QTI571) 100 mg film coated tablets once daily.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo to imatinib 100 mg film coated tablets

Primary Outcome Measure Information:

Title

Difference in Six-minute Walk Distance Test (6MWD) Between Imatinib and Placebo at 24 Weeks

Description

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Clinical Worsening Comparing Imatinib Versus Placebo for Adjudicated Cases

Description

Time Frame

24 weeks

Title

Change From Baseline in Right Atrial Pressure

Description

Time Frame

baseline and week 24

Title

Change From Baseline in Mean Pulmonary Arterial Pressure

Description

Time Frame

baseline and week 24

Title

Change From Baseline in Mean Pulmonary Capillary Wedge Pressure

Description

Time Frame

baseline and week 24

Title

Change From Baseline in Systemic Vascular Resistance

Description

Time Frame

baseline and week 24

Title

Change From Baseline in Pulmonary Vascular Resistance

Description

Time Frame

baseline and week 24

Title

Change From Baseline in Pulmonary Resistance Index

Description

Time Frame

baseline and week 24

Title

Change From Baseline in Cardiac Output

Description

Time Frame

24 weeks

Title

Change From Baseline in Systolic Arterial Blood Pressure

Description

Time Frame

baseline and week 24

Title

Change From Baseline in Diastolic Arterial Blood Pressure

Description

Time Frame

baseline and week 24

Title

Change From Baseline in Heart Rate

Description

Time Frame

24 weeks

Title

Change in Borg Dyspnea Score During 6-minute Walk Test

Description

Time Frame

week 24

Title

Covariance of End of Study CAMPHOR Score

Description

Time Frame

Week 24

Title

Plasma Concentration of QTI571 200 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant

Description

Time Frame

predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168

Title

Plasma Concentration of QTI571 400 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant

Description

Time Frame

predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion criteria 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 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Novartis Investigative Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

Facility Name

Novartis Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90024

Country

United States

Facility Name

Novartis Investigative Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Novartis Investigative Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Novartis Investigative Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Novartis Investigative Site

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33140

Country

United States

Facility Name

Novartis Investigative Site

City

Weston

State/Province

Florida

ZIP/Postal Code

33331

Country

United States

Facility Name

Novartis Investigative Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Novartis Investigative Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Novartis Investigative Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Facility Name

Novartis Investigative Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Novartis Investigative Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Novartis Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

Novartis Investigative Site

City

Minneola

State/Province

New York

ZIP/Postal Code

11501-3893

Country

United States

Facility Name

Novartis Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Novartis Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Novartis Investigative Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Novartis Investigative Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Novartis Investigative Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Novartis Investigative Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Novartis Investigative Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Novartis Investigative Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Novartis Investigative Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

Novartis Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Facility Name

Novartis Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Novartis Investigative Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37934

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Novartis Investigative Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53215

Country

United States

Facility Name

Novartis investigative site

City

Innsbruck

Country

Austria

Facility Name

Novartis Investigative Site

City

Vienna

Country

Austria

Facility Name

Novartis Investigative Site

City

Bruxelles

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

Country

Belgium

Facility Name

Novartis Investigative Site

City

Calgary

Country

Canada

Facility Name

Novartis Investigative Site

City

Edmonton

Country

Canada

Facility Name

Novartis Investigative Site

City

London

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

Country

Canada

Facility Name

Novartis Investigative Site

City

Ottawa

Country

Canada

Facility Name

Novartis investigative site

City

Toronto

Country

Canada

Facility Name

Novartis Investigative Site

City

Vancouver

Country

Canada

Facility Name

Novartis Investigative Site

City

Clamart Cedex

Country

France

Facility Name

Novartis Investigative Site

City

Berlin

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

Country

Germany

Facility Name

Novartis Investigative Site

City

Giessen

Country

Germany

Facility Name

Novartis Investigative Site

City

Greifswald

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

Country

Germany

Facility Name

Novartis Investigative Site

City

Heidelberg

Country

Germany

Facility Name

Novartis Investigative Site

City

Homburg

Country

Germany

Facility Name

Novartis Investigative Site

City

Koln

Country

Germany

Facility Name

Novartis investigative site

City

Lowenstein

Country

Germany

Facility Name

Novartis Investigative Site

City

Munchen

Country

Germany

Facility Name

Novartis Investigative Site

City

Regensberg

Country

Germany

Facility Name

Novartis Investigative Site

City

Wurzberg

Country

Germany

Facility Name

Novartis Investigative Site

City

Bologna

Country

Italy

Facility Name

Novartis Investigative Site

City

Pavia

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

Country

Italy

Facility Name

Novartis Investigative Site

City

Bunkyo-ku

Country

Japan

Facility Name

Novartis Investigative Site

City

Hamamatsu

Country

Japan

Facility Name

Novartis Investigative Site

City

Mitaka

Country

Japan

Facility Name

Novartis Investigative Site

City

Okayama

Country

Japan

Facility Name

Novartis Investigative Site

City

Sendai

Country

Japan

Facility Name

Novartis Investigative Site

City

Suita

Country

Japan

Facility Name

Novartis Investigative Site

City

Seoul

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Amsterdam

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Barcelona

Country

Spain

Facility Name

Novartis Investigative Site

City

Caceras

Country

Spain

Facility Name

Novartis Investigative Site

City

La Coruna

Country

Spain

Facility Name

Novartis investigative site

City

La Laguna

Country

Spain

Facility Name

Novartis Investigative Site

City

Las Palmas de Gran Canarias

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

Country

Spain

Facility Name

Novartis Investigative Site

City

Malaga

Country

Spain

Facility Name

Novartis Investigative Site

City

Santa Cruz de Tenerife

Country

Spain

Facility Name

Novartis Investigative Site

City

Santander

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

Country

Spain

Facility Name

Novartis investigative site

City

Valencia

Country

Spain

Facility Name

Novartis Investigative Site

City

Valladolid

Country

Spain

Facility Name

Novartis Investigative Site

City

Lund

Country

Sweden

Facility Name

Novartis Investigative Site

City

Stockholm

Country

Sweden

Facility Name

Novartis Investigative Site

City

Umea

Country

Sweden

Facility Name

Novartis Investigative Site

City

Uppsala

Country

Sweden

Facility Name

University Hospital Basel

City

Basel

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Bern

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Lausanne

Country

Switzerland

Facility Name

Novartis Investigative Site

City

St. Gallen

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Cambridge

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Clydebank

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Newcastle Upon Tyne

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Sheffield

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

26514759

Citation

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.

Results Reference

derived

PubMed Identifier

25367310

Citation

Querejeta 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.

Results Reference

derived

PubMed Identifier

24566799

Citation

Shah 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.

Results Reference

derived

PubMed Identifier

23403476

Citation

Hoeper 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.

Results Reference

derived

Links:

URL

http://www.phclinicaltrials.com

Description

Related Info

Learn more about this trial

Imatinib (QTI571) in Pulmonary Arterial Hypertension

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Imatinib (QTI571) in Pulmonary Arterial Hypertension (IMPRES)

Pulmonary Arterial Hypertension

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial