Imatinib (QTI571) in Pulmonary Arterial Hypertension (IMPRES)

February 16, 2016 updated by: Novartis Pharmaceuticals

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
202

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • Novartis Investigative Site
      • Vienna, Austria
        • Novartis Investigative Site
  • Belgium
      • Bruxelles, Belgium
        • Novartis Investigative Site
      • Leuven, Belgium
        • Novartis Investigative Site
  • Canada
      • Calgary, Canada
        • Novartis Investigative Site
      • Edmonton, Canada
        • Novartis Investigative Site
      • London, Canada
        • Novartis Investigative Site
      • Montreal, Canada
        • Novartis Investigative Site
      • Ottawa, Canada
        • Novartis Investigative Site
      • Toronto, Canada
        • Novartis Investigative Site
      • Vancouver, Canada
        • Novartis Investigative Site
  • France
      • Clamart Cedex, France
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany
        • Novartis Investigative Site
      • Dresden, Germany
        • Novartis Investigative Site
      • Giessen, Germany
        • Novartis Investigative Site
      • Greifswald, Germany
        • Novartis Investigative Site
      • Hamburg, Germany
        • Novartis Investigative Site
      • Hannover, Germany
        • Novartis Investigative Site
      • Heidelberg, Germany
        • Novartis Investigative Site
      • Homburg, Germany
        • Novartis Investigative Site
      • Koln, Germany
        • Novartis Investigative Site
      • Lowenstein, Germany
        • Novartis Investigative Site
      • Munchen, Germany
        • Novartis Investigative Site
      • Regensberg, Germany
        • Novartis Investigative Site
      • Wurzberg, Germany
        • Novartis Investigative Site
  • Italy
      • Bologna, Italy
        • Novartis Investigative Site
      • Pavia, Italy
        • Novartis Investigative Site
      • Pisa, Italy
        • Novartis Investigative Site
      • Roma, Italy
        • Novartis Investigative Site
  • Japan
      • Bunkyo-ku, Japan
        • Novartis Investigative Site
      • Hamamatsu, Japan
        • Novartis Investigative Site
      • Mitaka, Japan
        • Novartis Investigative Site
      • Okayama, Japan
        • Novartis Investigative Site
      • Sendai, Japan
        • Novartis Investigative Site
      • Suita, Japan
        • Novartis Investigative Site
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain
        • Novartis Investigative Site
      • Caceras, Spain
        • Novartis Investigative Site
      • La Coruna, Spain
        • Novartis Investigative Site
      • La Laguna, Spain
        • Novartis Investigative Site
      • Las Palmas de Gran Canarias, Spain
        • Novartis Investigative Site
      • Madrid, Spain
        • Novartis Investigative Site
      • Malaga, Spain
        • Novartis Investigative Site
      • Santa Cruz de Tenerife, Spain
        • Novartis Investigative Site
      • Santander, Spain
        • Novartis Investigative Site
      • Sevilla, Spain
        • Novartis Investigative Site
      • Valencia, Spain
        • Novartis Investigative Site
      • Valladolid, Spain
        • Novartis Investigative Site
  • Sweden
      • Lund, Sweden
        • Novartis Investigative Site
      • Stockholm, Sweden
        • Novartis Investigative Site
      • Umea, Sweden
        • Novartis Investigative Site
      • Uppsala, Sweden
        • Novartis Investigative Site
  • Switzerland
      • Basel, Switzerland
        • University Hospital Basel
      • Bern, Switzerland
        • Novartis Investigative Site
      • Lausanne, Switzerland
        • Novartis Investigative Site
      • St. Gallen, Switzerland
        • Novartis Investigative Site
  • United Kingdom
      • Cambridge, United Kingdom
        • Novartis Investigative Site
      • Clydebank, United Kingdom
        • Novartis Investigative Site
      • London, United Kingdom
        • Novartis Investigative Site
      • Newcastle Upon Tyne, United Kingdom
        • Novartis Investigative Site
      • Sheffield, United Kingdom
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Novartis Investigative Site
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Novartis Investigative Site
    • California
      • Los Angeles, California, United States, 90024
        • Novartis Investigative Site
      • San Francisco, California, United States, 94143
        • Novartis Investigative Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Novartis Investigative Site
    • Florida
      • Clearwater, Florida, United States, 33756
        • Novartis Investigative Site
      • Miami Beach, Florida, United States, 33140
        • Novartis Investigative Site
      • Weston, Florida, United States, 33331
        • Novartis Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Novartis Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Novartis Investigative Site
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Novartis Investigative Site
      • Boston, Massachusetts, United States, 02114
        • Novartis Investigative Site
      • Boston, Massachusetts, United States, 02118
        • Novartis Investigative Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Novartis Investigative Site
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Novartis Investigative Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Novartis Investigative Site
    • New York
      • Minneola, New York, United States, 11501-3893
        • Novartis Investigative Site
      • New York, New York, United States, 10029
        • Novartis Investigative Site
      • New York, New York, United States, 10032
        • Novartis Investigative Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Novartis Investigative Site
      • Cleveland, Ohio, United States, 44195
        • Novartis Investigative Site
      • Cleveland, Ohio, United States, 44106
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Novartis Investigative Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Novartis Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Novartis Investigative Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Novartis Investigative Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • Novartis Investigative Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37934
        • Novartis Investigative Site
    • Texas
      • Dallas, Texas, United States, 75390
        • Novartis Investigative Site
      • Houston, Texas, United States, 77030
        • Novartis Investigative Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: imatinib mesylate
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.
Drug: imatinib mesylate
Two or 4 imatinib mesylate (QTI571) 100 mg film coated tablets once daily.
Placebo Comparator: Placebo
Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments.
Drug: Placebo
Placebo to imatinib 100 mg film coated tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Worsening Comparing Imatinib Versus Placebo for Adjudicated Cases
Time Frame: 24 weeks
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.
24 weeks
Change From Baseline in Right Atrial Pressure
Time Frame: baseline and week 24
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.
baseline and week 24
Change From Baseline in Mean Pulmonary Arterial Pressure
Time Frame: baseline and week 24
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.
baseline and week 24
Change From Baseline in Mean Pulmonary Capillary Wedge Pressure
Time Frame: baseline and week 24
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.
baseline and week 24
Change From Baseline in Systemic Vascular Resistance
Time Frame: baseline and week 24
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.
baseline and week 24
Change From Baseline in Pulmonary Vascular Resistance
Time Frame: baseline and week 24
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.
baseline and week 24
Change From Baseline in Pulmonary Resistance Index
Time Frame: baseline and week 24
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.
baseline and week 24
Change From Baseline in Cardiac Output
Time Frame: 24 weeks
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.
24 weeks
Change From Baseline in Systolic Arterial Blood Pressure
Time Frame: baseline and week 24
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.
baseline and week 24
Change From Baseline in Diastolic Arterial Blood Pressure
Time Frame: baseline and week 24
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.
baseline and week 24
Change From Baseline in Heart Rate
Time Frame: 24 weeks
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.
24 weeks
Change in Borg Dyspnea Score During 6-minute Walk Test
Time Frame: week 24
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.
week 24
Covariance of End of Study CAMPHOR Score
Time Frame: Week 24
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.
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

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.
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CQTI571A2301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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