Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases) (ALTITUDE)

This study has been terminated.
(Lack of benefit and safety concern)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00549757
First received: October 24, 2007
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney.

AMENDMENT 4 RATIONALE (MARCH 2012) :

Protocol amendment 4 served to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addressed the subsequent Health Authorities request to implement a 12 month safety follow-up period (actual duration was 9 months in average) post study drug discontinuation.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Cardiovascular Disease
Drug: Aliskiren
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Determine Whether, in Patients With Type 2 Diabetes at High Risk for Cardiovascular and Renal Events, Aliskiren, on Top of Conventional Treatment, Reduces Cardiovascular and Renal Morbidity and Mortality

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of Participants With Occurrence of Primary Composite Endpoint (Core : Active Treatment Phase) [ Time Frame: Time from randomization to the first event (Maximum 50 months) ] [ Designated as safety issue: No ]

    Occurrence was defined as the first event of the following composite primary endpoint:

    • Cardiovascular (CV) death
    • Resuscitated sudden death
    • Non-fatal myocardial infarction (MI)
    • Non-fatal stroke
    • Unplanned hospitalization for heart failure (HF)
    • Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.
    • Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.

  • Percentage of Participants With Cardiovascular (CV) Death (Core: Active Treatment Phase) [ Time Frame: Time from randomization to the first event (Maximum 50 months) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Resuscitated Sudden Death (Core: Active Treatment Phase) [ Time Frame: Time from randomization to the first event (Maximum 50 Months) ] [ Designated as safety issue: No ]
    Resuscitated sudden death was adjudicated when a subject experiences sudden death or cardiac arrest and is successfully resuscitated by cardioversion, defibrillation or cardiopulmonary resuscitation with a meaningful recovery of consciousness. This definition excludes known transient losses of consciousness such as seizure or vasovagal episodes that do not reflect significant cardiac dysfunction.

  • Percentage of Participants With Fatal/Non-fatal Myocardial Infarction (MI) (Core: Active Treatment Phase) [ Time Frame: Time from randomization to the first event (Maximum 50 Months) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Fatal/Non-fatal Stroke (Core: Active Treatment Phase) [ Time Frame: Time from randomization to the first event (Maximum 50 Months) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Core: Active Treatment Phase) [ Time Frame: Time from randomization to the first event (Maximum 50 Months) ] [ Designated as safety issue: No ]
    ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death

  • Percentage of Participants With Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Core: Active Treatment Phase) [ Time Frame: Time from randomization to the first event (Maximum 50 Months) ] [ Designated as safety issue: No ]
    To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.

  • Percentage of Participants With Unplanned Hospitalization for Heart Failure (Core: Active Treatment Phase) [ Time Frame: Time from randomization to the first event (Maximum 50 Months) ] [ Designated as safety issue: No ]
  • Percentage of Participants With All Cause Mortality (Core: Active Treatment Phase) [ Time Frame: Time from randomization to the first event (Maximum 50 months) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Occurrence of Primary Composite Endpoint (Extension Phase) [ Time Frame: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) ] [ Designated as safety issue: No ]

    Occurrence was defined as the first event of the following composite primary endpoint:

    • Cardiovascular (CV) death
    • Resuscitated sudden death
    • Non-fatal myocardial infarction (MI)
    • Non-fatal stroke
    • Unplanned hospitalization for heart failure (HF)
    • Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.
    • Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.

  • Percentage of Participants With Cardiovascular (CV) Death (Extension Phase) [ Time Frame: from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Resuscitated Sudden Death (Extension Phase) [ Time Frame: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) ] [ Designated as safety issue: No ]
  • Percentage of Participants Fatal/Non-fatal Myocardial Infarction (MI) (Extension Phase) [ Time Frame: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 month in average) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Fatal/Non-fatal Stroke (Extension Phase) [ Time Frame: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Extension Phase) [ Time Frame: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) ] [ Designated as safety issue: No ]
    ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death

  • Percentage of Participants Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Extension Phase) [ Time Frame: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) ] [ Designated as safety issue: No ]
    To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.

  • Percentage of Participants With Unplanned Hospitalization for Heart Failure (Extension Phase) [ Time Frame: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) ] [ Designated as safety issue: No ]
  • Percentage of Participants With All Cause Mortality (Extension Phase) [ Time Frame: from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Core: Active Treatment Phase) [ Time Frame: Time from randomization to the first event (Maximum 50 months) ] [ Designated as safety issue: No ]

    Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint:

    • Cardiovascular (CV) death
    • Resuscitated sudden death
    • Non-fatal myocardial infarction (MI)
    • Non-fatal stroke
    • Unplanned hospitalization for heart failure (HF)

  • Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Core: Active Treatment Phase) [ Time Frame: Time from randomization to the first event (Maximum 50 months) ] [ Designated as safety issue: No ]

    Occurrence was defined as the first event of the following secondary renal composite endpoint:

    • Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.
    • Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory.The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.

  • Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Extension Phase) [ Time Frame: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) ] [ Designated as safety issue: No ]

    Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint:

    • Cardiovascular (CV) death
    • Resuscitated sudden death
    • Non-fatal myocardial infarction (MI)
    • Non-fatal stroke
    • Unplanned hospitalization for heart failure (HF)

  • Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Extension Phase) [ Time Frame: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) ] [ Designated as safety issue: No ]

    Occurrence was defined as the first event of the following secondary renal composite endpoint:

    • Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.
    • Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.


Other Outcome Measures:
  • Percentage of Participants With Angioedema/Angioedema-like or Colorectal Events (Core : Active Treatment Phase) [ Time Frame: Time from randomization to the first event (Maximum 50 months) ] [ Designated as safety issue: Yes ]
    AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures

  • Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) to Month 6 and to Last Measurement (Core : Active Treatment Phase) [ Time Frame: Baseline, Month 6 , last measurement (maximum at 50 months) ] [ Designated as safety issue: No ]

    Baseline is the geometric mean of last 3 measurements before visit 3, Post-baseline value is the geometric mean of last 3 measurements during each visit.

    Change from Baseline = Post - Baseline.


  • Mean Changes in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Month 3 and Month 6 (Core : Active Treatment Phase) [ Time Frame: Baseline to Month 3 and Month 6 ] [ Designated as safety issue: No ]

    The eGFR calculation was based on the Abbreviated Modification of Diet in Renal Disease (MDRD) Study Equation. Using this method, the applicable MDRD formula to calculate eGFR was as follows:

    Estimated GFR (mL/min/1.73 m^2) = 175 x (serum creatinine in mg/dL) -1.154 x (Age in years) -0.203 x (0.742 if female) x (1.210 if Black)

    Mean changes in eGFR from baseline to month 3 and month 6 were included for analysis. The LS Mean and Standard Error were based on an ANCOVA repeated-measure model with treatment, visit, treatment-by-visit and baseline eGFR as effect terms.


  • Percentage of Participants With Angioedema/Angioedema-like Events or Colorectal Events (Extension Phase) [ Time Frame: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) ] [ Designated as safety issue: Yes ]
    AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures.


Enrollment: 8606
Study Start Date: October 2007
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aliskiren

In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.

With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment

Drug: Aliskiren
Aliskiren 150 mg film-coated tablets
Placebo Comparator: Placebo

In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.

With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.

Drug: Placebo
Placebo to match aliskiren 150 mg film-coated tablets

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes and at least one of the following:

    • Macroalbuminuria and an eGFR ≥30 mL/min/1.73 m2
    • Microalbuminuria and a reduced kidney function (eGFR eGFR ≥30 and <60 mL/min/1.73 m2)
    • A history of CV disease (previous MI, previous stroke, heart failure, coronary artery disease, history of percutaneous coronary intervention, angiography proven stenosis ≥50% in at least one coronary artery and a reduced kidney function (eGFR ≥30 and <60 mL/min/1.73 m2)
  • Concomitant treatment should follow national guidelines and must include either an Angiotensin-converting-enzyme-inhibitor (ACEi) or an Angiotensin-receptor-blocker (ARB) but not both.

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Cardiovascular event or procedure ≤ 3 months prior to Visit 1
  • Unstable serum creatinine
  • Hypertension: Mean sitting systolic blood pressure (msSBP) ≥ 135 and < 170 mmHg or Mean sitting diastolic blood pressure (msDBP) ≥ 85 and < 110 mmHg unless treated with at least 3 anti-hypertensive medications
  • Hypertension msSBP ≥ 170 or msDBP ≥ 110 mmHg
  • Baseline Serum Potassium > 5.0 mmol/L
  • Patients who are treated with two renin-angiotensin-aldosterone-system-blockers
  • Patients with NYHA class III or IV heart failure
  • Known renal artery stenosis
  • Previous randomization into the AVOID trial (CSPP100C2201)

EXCLUSION SPECIFIC TO THE SAFETY FOLLOW-UP PERIOD:

- Aliskiren or aliskiren containing fixed combination products must not be used

Other protocol-defined inclusion/exclusion criteria applied

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549757

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Locations
United States, Alabama
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Birmingham, Alabama, United States, 35209
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Birmingham, Alabama, United States, 35235
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Huntsville, Alabama, United States, 35801
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Mobile, Alabama, United States, 36617
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Mobile, Alabama, United States, 36608
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Montgomery, Alabama, United States, 36106
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Muscle Shoals, Alabama, United States, 35662
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Peoria, Arizona, United States, 85381
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Phoenix, Arizona, United States, 85032
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Tucson, Arizona, United States, 85741
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Tucson, Arizona, United States, 85712
United States, Arkansas
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Fayetteville, Arkansas, United States, 72703
United States, California
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Burlingame, California, United States, 94010
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Fullerton, California, United States, 92835
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Huntington Beach, California, United States, 92648
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Oakland, California, United States, 94609
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Pasadena, California, United States, 91101
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Riverside, California, United States, 92501
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Spring Valley, California, United States, 91978-1522
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Torrance, California, United States, 90502
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Walnut Creek, California, United States, 94598
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Denver, Colorado, United States, 80209
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Bridgeport, Connecticut, United States, 06610
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Aventura, Florida, United States, 33180
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Boca Raton, Florida, United States, 33433
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Ft. Lauderdale, Florida, United States, 33311
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Jacksonville, Florida, United States, 32216
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Jacksonville, Florida, United States, 32204
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Jacksonville, Florida, United States, 32209
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West Palm Beach, Florida, United States, 33401
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Atlanta, Georgia, United States, 30309
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Augusta, Georgia, United States, 30909
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Augusta, Georgia, United States, 30904
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Cumming, Georgia, United States, 30041
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Honolulu, Hawaii, United States, 96813
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Honolulu, Hawaii, United States, 96814
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Champaign, Illinois, United States, 61820
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Lake Zurich, Illinois, United States, 60047
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Peoria, Illinois, United States, 61615
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Topeka, Kansas, United States, 66606
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Louisville, Kentucky, United States, 40202
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Metairie, Louisiana, United States, 70006
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Slidell, Louisiana, United States, 70458
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Baltimore, Maryland, United States, 21204
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Natick, Massachusetts, United States, 01760
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Worcester, Massachusetts, United States, 01609
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Ann Arbor, Michigan, United States, 48109
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Detroit, Michigan, United States, 48236
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Springfield, Missouri, United States, 65807
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St. Louis, Missouri, United States, 63110-1093
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St. Louis, Missouri, United States, 63141
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Fremont, Nebraska, United States, 68025
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Dover, New Hampshire, United States, 03820-2403
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Princeton Junction, New Jersey, United States, 08550
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Albuquerque, New Mexico, United States, 87106
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Lyndhurst, Ohio, United States, 44124
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Norman, Oklahoma, United States, 73069
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Allentown, Pennsylvania, United States, 18103
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Lansdale, Pennsylvania, United States, 19446
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Melrose Park, Pennsylvania, United States, 19027
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Philadelphia, Pennsylvania, United States, 19138
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Wyomissing, Pennsylvania, United States, 19610
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Warwick, Rhode Island, United States, 02886
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Aiken, South Carolina, United States, 29801
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Charleston, South Carolina, United States, 29425
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Greenville, South Carolina, United States, 29605
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Amarillo, Texas, United States, 79106
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McAllen, Texas, United States, 78501
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North Richland Hills, Texas, United States, 76180
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Plano, Texas, United States, 75024
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San Antonio, Texas, United States, 78229-4801
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San Antonio, Texas, United States, 78207
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San Antonio, Texas, United States, 78218
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Temple, Texas, United States, 76508-0002
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Bennington, Vermont, United States, 05201
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Burlington, Vermont, United States, 05401
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Alexandria, Virginia, United States, 22304-2315
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Burke, Virginia, United States, 22015
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Renton, Washington, United States, 98055
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Charleston, West Virginia, United States, 25301
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Appleton, Wisconsin, United States, 54911
Argentina
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Caba, Buenos Aires, Argentina, C1408INH
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Caba, Buenos Aires, Argentina, C1280AEB
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Caba, Buenos Aires, Argentina, C1181ACH
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Caba, Buenos Aires, Argentina, C1425AST
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Caba, Buenos Aires, Argentina, 1428
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Caba, Buenos Aires, Argentina, C1416DRJ
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Florida, Buenos Aires, Argentina, B1602BPD
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Lanus, Buenos Aires, Argentina, B8000XAV
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Ramos Mejia, Buenos Aires, Argentina, B1704ETD
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Zarate, Buenos Aires, Argentina, 2800
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Rosario, Santa Fe, Argentina, S2000DFD
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Rosario, Santa Fe, Argentina, S200CVD
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Rosario, Santa Fe, Argentina, S2001ODA
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Rosario, Santa Fe, Argentina, S2000AII
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Rosario, Santa Fe, Argentina, S2000CXH
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Buenos Aires, Argentina, C1405BCH
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Buenos aires, Argentina, C1120AAC
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Cordoba, Argentina, X5000IUG
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Cordoba, Argentina, X5000JHQ
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Cordoba, Argentina, X5000FGG
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Cordoba, Argentina, X5009BSN
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Cordoba, Argentina, X5000AAW
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Cordoba, Argentina, X5016KEH
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Cordoba, Argentina, X5000EVQ
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Cordoba, Argentina, 5000
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Corrientes, Argentina, W3400
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Santa Fe, Argentina, S3000FNF
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Santa Fe, Argentina, S3000FVA
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Santa Fe, Argentina, S3000FSO
Austria
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Bregenz, Austria, A-6900
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Feldkirch, Austria, 6807
Novartis Investigative Site
Graz, Austria, 8036
Novartis Investigative Site
Innsbruck, Austria, INNSBRUCK
Novartis Investigative Site
Salzburg, Austria, A-5020
Novartis Investigative Site
Vienna, Austria, 1030
Novartis Investigative Site
Wien, Austria, 1090
Novartis Investigative Site
Wien, Austria, A-1220
Novartis Investigative Site
Wien, Austria, A-1130
Belgium
Novartis Investigative Site
Bonheiden, Belgium, 2820
Novartis Investigative Site
Brugge, Belgium, 8000
Novartis Investigative Site
Brussel, Belgium, 9100
Novartis Investigative Site
Bruxelles, Belgium, 1070
Novartis Investigative Site
Bruxelles, Belgium, 1200
Novartis Investigative Site
Charleroi, Belgium, 6000
Novartis Investigative Site
De Pinte, Belgium, 9840
Novartis Investigative Site
Edegem, Belgium, 2650
Novartis Investigative Site
Genk, Belgium, 3600
Novartis Investigative Site
Gent, Belgium, 9000
Novartis Investigative Site
Hasselt, Belgium, 3500
Novartis Investigative Site
Kortrijk, Belgium, 8500
Novartis Investigative Site
La Louvière, Belgium, 7100
Novartis Investigative Site
Leuven, Belgium, 3000
Novartis Investigative Site
Liege, Belgium, 4000
Novartis Investigative Site
Roeselare, Belgium, 8800
Novartis Investigative Site
Ronse, Belgium, 9600
Novartis Investigative Site
Seraing, Belgium, 4100
Novartis Investigative Site
Sint-Gillis-Waas, Belgium, 9170
Novartis Investigative Site
Turnhout, Belgium, 2300
Novartis Investigative Site
Vilvoorde, Belgium, 1800
Novartis Investigative Site
Willebroek, Belgium, 2830
Brazil
Novartis Investigative Site
Salvador, BA, Brazil, 40050-410
Novartis Investigative Site
Fortaleza, CE, Brazil, 60430-370
Novartis Investigative Site
Fortaleza, CE, Brazil, 60120-021
Novartis Investigative Site
Vitoria, ES, Brazil, 29040-091
Novartis Investigative Site
Juiz de Fora, MG, Brazil, 36036-110
Novartis Investigative Site
Belem, PA, Brazil, 66073-000
Novartis Investigative Site
Rio de Janeiro, RJ, Brazil, 20551-030
Novartis Investigative Site
Rio de Janeiro, RJ, Brazil, 20020-020
Novartis Investigative Site
Porto Alegre, RS, Brazil, 90020-090
Novartis Investigative Site
Campinas, SP, Brazil, 13083-190
Novartis Investigative Site
Campinas, SP, Brazil, 13060-904
Novartis Investigative Site
Marilia, SP, Brazil, 17519-030
Novartis Investigative Site
Santos, SP, Brazil, 11045-904
Novartis Investigative Site
Sao Jose do Rio Preto, SP, Brazil, 15090-000
Novartis Investigative Site
Sorocaba, SP, Brazil, 18030-210
Novartis Investigative Site
São Paulo, SP, Brazil, 05403-000
Novartis Investigative Site
São Paulo, SP, Brazil, 04023-900
Canada, Alberta
Novartis Investigative Site
Edmonton, Alberta, Canada, T5N 3Y6
Novartis Investigative Site
Edmonton, Alberta, Canada, T5J 3N4
Canada, British Columbia
Novartis Investigative Site
Vancouver, British Columbia, Canada, V6E 1M7
Canada, Manitoba
Novartis Investigative Site
Winnipeg, Manitoba, Canada, R3E 3P4
Novartis Investigative Site
Winnipeg, Manitoba, Canada, R2V 4W3
Canada, Newfoundland and Labrador
Novartis Investigative Site
Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
Novartis Investigative Site
St. John's, Newfoundland and Labrador, Canada, A1E 4J8
Canada, Ontario
Novartis Investigative Site
Brampton, Ontario, Canada, L6Z 4N5
Novartis Investigative Site
Burlington, Ontario, Canada, L7M 4Y1
Novartis Investigative Site
Cambridge, Ontario, Canada, N1R 6V6
Novartis Investigative Site
Courtice, Ontario, Canada, L1E 3C3
Novartis Investigative Site
Etobicoke, Ontario, Canada, M9R 4E1
Novartis Investigative Site
London, Ontario, Canada, N6A 4G5
Novartis Investigative Site
North Bay, Ontario, Canada, P1B 2H3
Novartis Investigative Site
Oakville, Ontario, Canada, L6H 3P1
Novartis Investigative Site
Oshawa, Ontario, Canada, L1J 2K1
Novartis Investigative Site
Ottawa, Ontario, Canada, K1H 7W9
Novartis Investigative Site
Scarborough, Ontario, Canada, M1H 3G4
Novartis Investigative Site
Thornhill, Ontario, Canada, L4J 8L7
Novartis Investigative Site
Toronto, Ontario, Canada, N6G 4X8
Novartis Investigative Site
Toronto, Ontario, Canada, M4G 3E8
Novartis Investigative Site
Toronto, Ontario, Canada, M4N 3M5
Novartis Investigative Site
Toronto, Ontario, Canada, M5C 2T2
Canada, Quebec
Novartis Investigative Site
Greenfield Park, Quebec, Canada, J4V 2H1
Novartis Investigative Site
Mirabel, Quebec, Canada, J7J 2K8
Novartis Investigative Site
Montreal, Quebec, Canada, H1T 2M4
Novartis Investigative Site
Pointe-Claire, Quebec, Canada, H9R 4S3
Novartis Investigative Site
Québec, Quebec, Canada, G1G 3Y8
Novartis Investigative Site
Sainte-Foy, Quebec, Canada, G1V 4G5
Novartis Investigative Site
Sainte-Foy, Quebec, Canada, G1W 4R4
Novartis Investigative Site
Sherbrooke, Quebec, Canada, J1G 5K2
Novartis Investigative Site
Ste-Foy, Quebec, Canada, G1V 4G2
Novartis Investigative Site
Trois-Rivières, Quebec, Canada, G8Z 3R9
Canada, Saskatchewan
Novartis Investigative Site
Saskatoon, Saskatchewan, Canada, S7H 5M3
Canada
Novartis Investigative Site
Ouest-Montreal, Canada, H2W1R7
China, Beijing
Novartis Investigative Site
Beijing, Beijing, China, 100730
Novartis Investigative Site
Beijing, Beijing, China, 100044
Novartis Investigative Site
Beijing, Beijing, China, 100083
China, Chongqing
Novartis Investigative Site
Chongqing, Chongqing, China, 400016
Novartis Investigative Site
Chongqing, Chongqing, China
China, Fujian
Novartis Investigative Site
Fuzhou, Fujian, China, 350025
China, Guangdong
Novartis Investigative Site
Guangzhou, Guangdong, China, 510180
China, Hebei
Novartis Investigative Site
Shijiazhuang, Hebei, China, 050051
China, Heilongjiang
Novartis Investigative Site
Harbin, Heilongjiang, China, 150001
Novartis Investigative Site
Harbin, Heilongjiang, China, 150086
China, Hubei
Novartis Investigative Site
Wuhan, Hubei, China, 430030
China, Hunan
Novartis Investigative Site
Changsha, Hunan, China, 410008
Novartis Investigative Site
Changsha City, Hunan, China, 410011
China, Jiangsu
Novartis Investigative Site
Nanjing, Jiangsu, China, 210006
Novartis Investigative Site
Nanjing, Jiangsu, China, 210029
Novartis Investigative Site
Nanjing, Jiangsu, China, 210008
Novartis Investigative Site
Nanjing, Jiangsu, China, 210009
Novartis Investigative Site
Suzhou, Jiangsu, China, 215004
China, Liaoning
Novartis Investigative Site
Dalian, Liaoning, China, 116011
Novartis Investigative Site
Shenyang, Liaoning, China, 110003
China, Shandong
Novartis Investigative Site
Qingdao, Shandong, China, 266011
China, Shanxi
Novartis Investigative Site
Xi'an, Shanxi, China, 710032
Novartis Investigative Site
Xi'an, Shanxi, China, 710061
China, Sichuan
Novartis Investigative Site
Chengdu, Sichuan, China, 610041
China, Yunnan
Novartis Investigative Site
Kunming, Yunnan, China, 650101
China, Zhejiang
Novartis Investigative Site
Hangzhou, Zhejiang, China, 310009
Novartis Investigative Site
Hangzhou, Zhejiang, China, 310016
Novartis Investigative Site
Hangzhou, Zhejiang, China, 310003
Novartis Investigative Site
Hangzhou, Zhejiang, China, 310013
China
Novartis Investigative Site
Beijing, China, 100176
Novartis Investigative Site
Beijing, China, 100034
Novartis Investigative Site
Beijing, China, 100088
Novartis Investigative Site
Beijing, China, 100029
Novartis Investigative Site
Beijing, China, 100028
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Chengdu, China, 610072
Novartis Investigative Site
Chongqing, China, 400038
Novartis Investigative Site
Dalian, China
Novartis Investigative Site
Guangzhou, China, 510000
Novartis Investigative Site
Shanghai, China, 200233
Novartis Investigative Site
Shanghai, China, 200003
Novartis Investigative Site
Shanghai, China, 200025
Novartis Investigative Site
Shanghai, China, 200031
Novartis Investigative Site
Tianjin, China, 300142
Novartis Investigative Site
Tianjin, China, 300052
Colombia
Novartis Investigative Site
Bogotá, Colombia
Novartis Investigative Site
Cali, Colombia
Novartis Investigative Site
Florida Blanca, Colombia
Novartis Investigative Site
Medellín, Colombia
Czech Republic
Novartis Investigative Site
Brno, Czech Republic, 61300
Novartis Investigative Site
Brno-Bohunice, Czech Republic, 639 01
Novartis Investigative Site
Ceske Budejovice, Czech Republic, 370 87
Novartis Investigative Site
Ostrava, Czech Republic, 702 00
Novartis Investigative Site
Pardubice, Czech Republic, 53002
Novartis Investigative Site
Pisek, Czech Republic, 397 01
Novartis Investigative Site
Prague 2, Czech Republic, 128 08
Novartis Investigative Site
Prague 2, Czech Republic, 128 02
Novartis Investigative Site
Prague 4 - Krc, Czech Republic, 14059
Novartis Investigative Site
Prague 5 - Motol, Czech Republic, 15112
Denmark
Novartis Investigative Site
Aalborg, Denmark, DK-9100
Novartis Investigative Site
Copenhagen NV, Denmark, DK-2400
Novartis Investigative Site
Frederiksberg, Denmark, DK-2000
Novartis Investigative Site
Gentofte, Denmark, DK-2820
Novartis Investigative Site
Hillerød, Denmark, DK-3400
Novartis Investigative Site
Hvidovre, Denmark, 2650
Novartis Investigative Site
Roskilde, Denmark, DK-4000
Novartis Investigative Site
Slagelse, Denmark, DK-4200
Novartis Investigative Site
Svendborg, Denmark, DK-5700
Novartis Investigative Site
Århus, Denmark, DK-8000
Finland
Novartis Investigative Site
Helsinki, Finland, 00250
Novartis Investigative Site
Hyvinkää, Finland, FIN-05850
Novartis Investigative Site
Kajaani, Finland, FIN-87140
Novartis Investigative Site
Kuopio, Finland, FIN-70211
Novartis Investigative Site
Lohja, Finland, FIN-08200
Novartis Investigative Site
Oulu, Finland, 90100
Novartis Investigative Site
OYS, Finland, FIN-90029
Novartis Investigative Site
Pori, Finland, 28120
Novartis Investigative Site
Tammisaari, Finland, 10600
Novartis Investigative Site
Tampere, Finland, 33520
Novartis Investigative Site
Valkeakoski, Finland, 37600
France
Novartis Investigative Site
Besancon Cedex, France, 25030
Novartis Investigative Site
Bondy, France, 93143
Novartis Investigative Site
Corbeil Essonnes, France, 91100
Novartis Investigative Site
Grenoble, France, 38043
Novartis Investigative Site
La Rochelle, France, 17019
Novartis Investigative Site
Lagny sur Marne, France, 77405
Novartis Investigative Site
Limoges Cedex, France, 87042
Novartis Investigative Site
Lyon, France, 69437
Novartis Investigative Site
Lyon Cedex 03, France, 69394
Novartis Investigative Site
Paris cedex 18, France, 75877
Novartis Investigative Site
Paris Cedex 4, France, 75181
Novartis Investigative Site
Poitiers Cedex, France, 86021
Germany
Novartis Investigative Site
Aschaffenburg, Germany, 63739
Novartis Investigative Site
Aschaffenburg, Germany, 63741
Novartis Investigative Site
Asslar, Germany, 35614
Novartis Investigative Site
Bad Oeynhausen, Germany, 32545
Novartis Investigative Site
Barsinghausen, Germany, 30890
Novartis Investigative Site
Bensheim, Germany, 64625
Novartis Investigative Site
Berlin, Germany, 14193
Novartis Investigative Site
Berlin, Germany, 13055
Novartis Investigative Site
Berlin, Germany, 13597
Novartis Investigative Site
Bonn, Germany, 53105
Novartis Investigative Site
Bottrop, Germany, 46242
Novartis Investigative Site
Bremen, Germany, 28277
Novartis Investigative Site
Bretten, Germany, 75015
Novartis Investigative Site
Cloppenburg, Germany, 49661
Novartis Investigative Site
Dippoldiswalde, Germany, 01744
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Dresden, Germany, 01127
Novartis Investigative Site
Duesseldorf, Germany, 40210
Novartis Investigative Site
Essen, Germany, 45134
Novartis Investigative Site
Essen, Germany, 45138
Novartis Investigative Site
Essen, Germany, 45127
Novartis Investigative Site
Fuldatal, Germany, 34233
Novartis Investigative Site
Göttingen, Germany, 37075
Novartis Investigative Site
Hagen, Germany, 58095
Novartis Investigative Site
Hamburg, Germany, 22393
Novartis Investigative Site
Hamburg, Germany, 22335
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Heilbronn, Germany, 74076
Novartis Investigative Site
Heilbronn, Germany, 74072
Novartis Investigative Site
Ingelheim, Germany, 55218
Novartis Investigative Site
Jena, Germany, 07743
Novartis Investigative Site
Kassel, Germany, 34117
Novartis Investigative Site
Krefeld, Germany, 47798
Novartis Investigative Site
Magdeburg, Germany, 39120
Novartis Investigative Site
Mainz, Germany, 55131
Novartis Investigative Site
Messkirch, Germany, 88605
Novartis Investigative Site
Muehldorf am Inn, Germany, 84453
Novartis Investigative Site
Neuwied, Germany, 56564
Novartis Investigative Site
Offenbach, Germany, 63065
Novartis Investigative Site
Rehburg-Loccum, Germany, 31547
Novartis Investigative Site
Riesa, Germany, 01587
Novartis Investigative Site
Schauenburg-Elgershausen, Germany, 34270
Novartis Investigative Site
Schwabenheim, Germany, 55270
Novartis Investigative Site
St. Ingbert - Oberwuerzbach, Germany, 66386
Novartis Investigative Site
Ursensollen, Germany, 92289
Novartis Investigative Site
Wetter, Germany, 58300
Novartis Investigative Site
Wiehl, Germany, 51674
Novartis Investigative Site
Wiesbaden, Germany, 65183
Novartis Investigative Site
Wuerzburg, Germany, 97072
Greece
Novartis Investigative Site
Alexandroupolis, Greece, GR 68 100
Novartis Investigative Site
Athens, Greece, GR 11527
Novartis Investigative Site
Athens, Greece, GR 115 27
Novartis Investigative Site
Athens, Greece, GR 115 21
Novartis Investigative Site
Athens, Greece, GR 115 22
Novartis Investigative Site
Athens, Greece
Novartis Investigative Site
Athens - GR, Greece, 10676
Novartis Investigative Site
Ioannina, Greece, GR 45500
Novartis Investigative Site
Patras, Greece, 26500
Novartis Investigative Site
Piraeurs, Greece, GR 184 54
Novartis Investigative Site
Thessaloniki, Greece, 57001
Novartis Investigative Site
Thessaloniki, Greece, GR 546 39
Guatemala
Novartis Investigative Site
Guatemala City, Guatemala, 01011
Novartis Investigative Site
Guatemala City, Guatemala, 01015
Novartis Investigative Site
Guatemala City, Guatemala, 01001
Novartis Investigative Site
Guatemala City, Guatemala, 01010
Hungary
Novartis Investigative Site
Baja, Hungary, 6500
Novartis Investigative Site
Balatonfured, Hungary, 8230
Novartis Investigative Site
Budapest, Hungary, 1085
Novartis Investigative Site
Budapest, Hungary, 1062
Novartis Investigative Site
Budapest, Hungary, 1096
Novartis Investigative Site
Budapest, Hungary, 1115
Novartis Investigative Site
Budapest, Hungary, H-1032
Novartis Investigative Site
Budapest, Hungary, 1083
Novartis Investigative Site
Debrecen, Hungary, 4004
Novartis Investigative Site
Debrecen, Hungary, 4032
Novartis Investigative Site
Gyula, Hungary, 5703
Novartis Investigative Site
Kaposvar, Hungary, 7400
Novartis Investigative Site
Miskolc, Hungary, 3526
Novartis Investigative Site
Pecs, Hungary, 7324
Novartis Investigative Site
Szeged, Hungary, 6720
Novartis Investigative Site
Zalaegerszeg, Hungary, 8900
India
Novartis Investigative Site
Hyderabad, Andhra Pradesh, INDIA, India, 500034
Novartis Investigative Site
Hyderabad, Andhra Pradesh, India, 500001
Novartis Investigative Site
Hyderabad, Andhra Pradesh, India, 500018
Novartis Investigative Site
Hyderabad, Andhra Pradesh, India, 500012
Novartis Investigative Site
Ahmedabad, Gujarat, India, 380014
Novartis Investigative Site
Bangalore, Karnataka, India, 560054
Novartis Investigative Site
Banglaore, Karnataka, India, 560038
Novartis Investigative Site
Mangalore, Karnataka, India, 575001
Novartis Investigative Site
Kochi, Kerala, India, 682 026
Novartis Investigative Site
Mumbai, Maharashtra, India, 400008
Novartis Investigative Site
Pune, Maharashtra, India, 411011
Novartis Investigative Site
Pune, Maharashtra, India, 411030
Novartis Investigative Site
Chennai, Tamil Nadu, India, 600013
Novartis Investigative Site
Vellore, Tamil Nadu, India, 632004
Novartis Investigative Site
Bangalore, India, 560 034
Novartis Investigative Site
Chennai, India, 600010
Novartis Investigative Site
Chennai, India, 600086
Novartis Investigative Site
Hyderabad, India, 500 063
Novartis Investigative Site
Kolkota, India, 700020
Novartis Investigative Site
New Delhi, India, 110 029
Italy
Novartis Investigative Site
L'Aquila, AQ, Italy, 67100
Novartis Investigative Site
Bergamo, BG, Italy, 24128
Novartis Investigative Site
Belluno, BL, Italy, 32100
Novartis Investigative Site
Bologna, BO, Italy, 40138
Novartis Investigative Site
Campobasso, CB, Italy, 86100
Novartis Investigative Site
Caserta, CE, Italy, 81100
Novartis Investigative Site
Chieti, CH, Italy, 66100
Novartis Investigative Site
Cuneo, CN, Italy, 12100
Novartis Investigative Site
Cosenza, CS, Italy, 87100
Novartis Investigative Site
Catanzaro, CZ, Italy, 88100
Novartis Investigative Site
Cona, FE, Italy, 44100
Novartis Investigative Site
Foggia, FG, Italy, 71100
Novartis Investigative Site
Firenze, FI, Italy, 50134
Novartis Investigative Site
Arenzano, GE, Italy, 16011
Novartis Investigative Site
Genova, GE, Italy, 16132
Novartis Investigative Site
Pozzilli, IS, Italy, 86077
Novartis Investigative Site
Lecco, LC, Italy, 23900
Novartis Investigative Site
Monza, MB, Italy, 20900
Novartis Investigative Site
Milano, MI, Italy, 20157
Novartis Investigative Site
Milano, MI, Italy, 20132
Novartis Investigative Site
Milano, MI, Italy, 20146
Novartis Investigative Site
Milano, MI, Italy, 20123
Novartis Investigative Site
Passirana di Rho, MI, Italy, 20017
Novartis Investigative Site
Palermo, PA, Italy, 90127
Novartis Investigative Site
Perugia, PG, Italy, 06100
Novartis Investigative Site
Pisa, PI, Italy, 56126
Novartis Investigative Site
Pisa, PI, Italy, 56124
Novartis Investigative Site
Pordenone, PN, Italy, 33170
Novartis Investigative Site
Parma, PR, Italy, 43100
Novartis Investigative Site
Casorate Primo, PV, Italy, 27022
Novartis Investigative Site
Pavia, PV, Italy, 27100
Novartis Investigative Site
Stradella, PV, Italy, 27049
Novartis Investigative Site
Ravenna, RA, Italy, 48100
Novartis Investigative Site
Roma, RM, Italy, 00163
Novartis Investigative Site
Roma, RM, Italy, 00122
Novartis Investigative Site
Roma, RM, Italy, 00186
Novartis Investigative Site
Roma, RM, Italy, 00161
Novartis Investigative Site
Roma, RM, Italy, 00157
Novartis Investigative Site
Roma, RM, Italy, 00189
Novartis Investigative Site
Roma, RM, Italy, 00133
Novartis Investigative Site
Cava De' Tirreni, SA, Italy, 84013
Novartis Investigative Site
Mercato San Severino, SA, Italy, 84085
Novartis Investigative Site
Salerno, SA, Italy, 84125
Novartis Investigative Site
Siena, SI, Italy, 53100
Novartis Investigative Site
Olbia, SS, Italy, 07026
Novartis Investigative Site
Sassari, SS, Italy, 07100
Novartis Investigative Site
Torino, TO, Italy, 10126
Novartis Investigative Site
Torino, TO, Italy, 10154
Novartis Investigative Site
Torino, TO, Italy, 10128
Novartis Investigative Site
Vittorio Veneto, TV, Italy, 31029
Novartis Investigative Site
San Daniele Del Friuli, UD, Italy, 33038
Novartis Investigative Site
Udine, UD, Italy, 33100
Novartis Investigative Site
Venezia, VE, Italy, 30174
Novartis Investigative Site
Verona, VR, Italy, 37126
Novartis Investigative Site
Isernia, Italy, 86170
Novartis Investigative Site
Napoli, Italy, 80131
Japan
Novartis Investigative Site
Nagoya, Aichi, Japan, 462-0825
Novartis Investigative Site
Nagoya, Aichi, Japan, 462-0802
Novartis Investigative Site
Nagoya, Aichi, Japan, 455-8530
Novartis Investigative Site
Nagoya, Aichi, Japan, 460-0001
Novartis Investigative Site
Nagoya, Aichi, Japan, 451-8511
Novartis Investigative Site
Asahi, Chiba, Japan, 289-2511
Novartis Investigative Site
Kasuga, Fukuoka, Japan, 816-0864
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan, 800-0296
Novartis Investigative Site
Koriyama-city, Fukushima, Japan, 963-8851
Novartis Investigative Site
Asahikawa, Hokkaido, Japan, 078-8211
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 060-0033
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 003-0023
Novartis Investigative Site
Sapporo-city, Hokkaido, Japan, 060-8648
Novartis Investigative Site
Toride-city, Ibaraki, Japan, 302-0022
Novartis Investigative Site
Takamatsu, Kagawa, Japan, 7600076
Novartis Investigative Site
Aira-city, Kagoshima, Japan, 899-5431
Novartis Investigative Site
Isehara-city, Kanagawa, Japan, 259-1131
Novartis Investigative Site
Kawasaki, Kanagawa, Japan, 210-0852
Novartis Investigative Site
Yatsushiro, Kumamoto, Japan, 866-8660
Novartis Investigative Site
Kyoto-city, Kyoto, Japan, 615-0035
Novartis Investigative Site
Kyoto-city, Kyoto, Japan, 612-8555
Novartis Investigative Site
Sendai-city, Miyagi, Japan, 980-8574
Novartis Investigative Site
Suwa, Nagano, Japan, 392-8510
Novartis Investigative Site
Okayama-city, Okayama, Japan, 700-8558
Novartis Investigative Site
Takatsuki-city, Osaka, Japan, 569-1096
Novartis Investigative Site
Toyonaka, Osaka, Japan, 561-0871
Novartis Investigative Site
Yao-city, Osaka, Japan, 581-0011
Novartis Investigative Site
Tokorozawa, Saitama, Japan, 351-1151
Novartis Investigative Site
Ohtsu-city, Shiga, Japan, 520-2192
Novartis Investigative Site
Shimizu, Shizuoka, Japan, 411-8611
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 113-8655
Novartis Investigative Site
Chuo-ku, Tokyo, Japan, 103-0002
Novartis Investigative Site
Takaoka, Toyama, Japan, 933-0955
Novartis Investigative Site
Oita, Japan, 870-0192
Novartis Investigative Site
Oita, Japan, 870-0039
Novartis Investigative Site
Okayama, Japan, 701-1192
Korea, Republic of
Novartis Investigative Site
Ansan, Gyeonggi-do, Korea, Republic of, 425-801
Novartis Investigative Site
Anyang, Gyeonggi-do, Korea, Republic of, 431-070
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 120-752
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 110 744
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 135-710
Novartis Investigative Site
Bundang, Seongnam, Korea, Republic of, 463-707
Novartis Investigative Site
Busan, Korea, Republic of, 602-739
Novartis Investigative Site
Daejeon, Korea, Republic of, 301-747
Novartis Investigative Site
Incheon, Korea, Republic of, 400-712
Novartis Investigative Site
Pusan, Korea, Republic of, 614-735
Novartis Investigative Site
Seoul, Korea, Republic of, 156-707
Novartis Investigative Site
Seoul, Korea, Republic of, 152-703
Novartis Investigative Site
Seoul, Korea, Republic of, 137-701
Novartis Investigative Site
Seoul, Korea, Republic of, 136 705
Novartis Investigative Site
Seoul, Korea, Republic of, 135-720
Novartis Investigative Site
Taegu, Korea, Republic of, 700 - 721
Lithuania
Novartis Investigative Site
Kaunas, Lithuania, 50009
Novartis Investigative Site
Klaipeda, Lithuania, 92304
Novartis Investigative Site
Vilnius, Lithuania, LT-08661
Novartis Investigative Site
Vilnius, Lithuania
Netherlands
Novartis Investigative Site
Alkmaar, Netherlands, 1851 JD
Novartis Investigative Site
Almelo, Netherlands, 7609 PP
Novartis Investigative Site
Amersfoort, Netherlands, 3800 BM
Novartis Investigative Site
Amsterdam, Netherlands, 1061 AE
Novartis Investigative Site
Apeldoorn, Netherlands, 7334 DZ
Novartis Investigative Site
Arnhem, Netherlands, 6815 AD
Novartis Investigative Site
Breda, Netherlands, 4818 CK
Novartis Investigative Site
Delft, Netherlands, 2625 AD
Novartis Investigative Site
Den Helder, Netherlands, 1782 GZ
Novartis Investigative Site
Deventer, Netherlands, 7416 SE
Novartis Investigative Site
Doetinchem, Netherlands, 7009 BL
Novartis Investigative Site
Dordrecht, Netherlands, 3318AT
Novartis Investigative Site
Eindhoven, Netherlands, 5623 EJ
Novartis Investigative Site
Eindhoven, Netherlands, 5631 BM
Novartis Investigative Site
Goes, Netherlands, 4462 RA
Novartis Investigative Site
Groningen, Netherlands, 9713 GZ
Novartis Investigative Site
Heerlen, Netherlands, 6419 PC
Novartis Investigative Site
Hoogeveen, Netherlands, 7909 AA
Novartis Investigative Site
Hoogwoud, Netherlands, 1718 BG
Novartis Investigative Site
Losser, Netherlands, 7581 BV
Novartis Investigative Site
Meppel, Netherlands, 7943 KA
Novartis Investigative Site
Nieuwegein, Netherlands, 3435 CM
Novartis Investigative Site
Oude Pekela, Netherlands, 9665 AR
Novartis Investigative Site
Rotterdam, Netherlands, 3083 AN
Novartis Investigative Site
Rotterdam, Netherlands, 3045 PM
Novartis Investigative Site
Rotterdam, Netherlands, 3015 CE
Novartis Investigative Site
Tiel, Netherlands, 4002 WP
Novartis Investigative Site
Utrecht, Netherlands, 3508 GA
Novartis Investigative Site
Venlo, Netherlands, 5912 BL
Novartis Investigative Site
Woerden, Netherlands, 3443 GG
Novartis Investigative Site
Zwijndrecht, Netherlands, NL-3331 LZ
Novartis Investigative Site
Zwolle, Netherlands, 8025 AB
Norway
Novartis Investigative Site
Bergen, Norway, 5013
Novartis Investigative Site
Fredrikstad, Norway, 1607
Novartis Investigative Site
Horten, Norway, 3191
Novartis Investigative Site
Hønefoss, Norway, 3515
Novartis Investigative Site
Oslo, Norway, 0160
Novartis Investigative Site
Skedsmokorset, Norway, 2020
Novartis Investigative Site
Skien, Norway, 3722
Novartis Investigative Site
Spikkestad, Norway, 3430
Novartis Investigative Site
Stavanger, Norway, 4011
Novartis Investigative Site
Svelvik, Norway, 3060
Novartis Investigative Site
Tromsø, Norway, NO-9038
Novartis Investigative Site
Trondheim, Norway, NO-7011
Novartis Investigative Site
Tønsberg, Norway, 3103
Peru
Novartis Investigative Site
Bellavista, Lima, Peru, Callao 02
Novartis Investigative Site
Cercado de Lima, Lima, Peru, 01
Novartis Investigative Site
San Borja, Lima, Peru, 41
Novartis Investigative Site
San Isidro, Lima, Peru, 27
Novartis Investigative Site
San Martin de Porres, Lima, Peru, 31
Novartis Investigative Site
Santiago de Surco, Lima, Peru, 33
Portugal
Novartis Investigative Site
Almada, Portugal, 2801-951
Novartis Investigative Site
Amadora, Portugal, 2720-276
Novartis Investigative Site
Coimbra, Portugal, 3000-075
Novartis Investigative Site
Linda-a-Velha, Portugal, 2799-523
Novartis Investigative Site
Lisboa, Portugal, 1250-203
Novartis Investigative Site
Lisboa, Portugal, 1649-035
Novartis Investigative Site
Lisboa, Portugal, 1169-024
Novartis Investigative Site
Lisboa, Portugal, 1495-005
Novartis Investigative Site
Matosinhos, Portugal, 4454-509
Novartis Investigative Site
Portimão, Portugal, 8500-388
Novartis Investigative Site
Porto, Portugal, 4200-319
Novartis Investigative Site
Santa Maria da Feira, Portugal, 4520-211
Novartis Investigative Site
Santarém, Portugal, 2000-153
Puerto Rico
Novartis Investigative Site
Ponce, Puerto Rico, 00716
Novartis Investigative Site
Ponce, Puerto Rico, 00733-1471
Singapore
Novartis Investigative Site
Singapore, Singapore, 308433
Novartis Investigative Site
Singapore, Singapore, 119074
Novartis Investigative Site
Singapore, Singapore, 159964
Novartis Investigative Site
Singapore, Singapore, 168752
Novartis Investigative Site
Singapore, Singapore, 169608
Slovakia
Novartis Investigative Site
Bratislava, Slovak Republic, Slovakia, 826 06
Novartis Investigative Site
Kosice, Slovak Republic, Slovakia, 040 22
Novartis Investigative Site
Zilina, Slovak Republic, Slovakia, 010 01
Novartis Investigative Site
Banksa Bystrica, Slovakia, SK 97 517
Novartis Investigative Site
Bratislava, Slovakia, 81369
Novartis Investigative Site
Bratislava, Slovakia, 833 48
Novartis Investigative Site
Bratislava, Slovakia, 851 07
Novartis Investigative Site
Bratislava, Slovakia, 812 72
Novartis Investigative Site
Bratislava, Slovakia, 811 08
Novartis Investigative Site
Kosice, Slovakia, 040 01
Novartis Investigative Site
Lubochna, Slovakia, SK 03491
Novartis Investigative Site
Lucenec, Slovakia, 98439
Novartis Investigative Site
Martin, Slovakia, 03601
Novartis Investigative Site
Nitra, Slovakia, 949 01
Novartis Investigative Site
Piestany, Slovakia, 921 01
Novartis Investigative Site
Prievidza, Slovakia, 971 01
Novartis Investigative Site
Trstena, Slovakia, 549 16
South Africa
Novartis Investigative Site
Somerset West, Western Cape, South Africa, 7130
Novartis Investigative Site
Cape Town, South Africa, 7925
Novartis Investigative Site
Durban, South Africa, 4001
Novartis Investigative Site
Durban, South Africa, 4052
Novartis Investigative Site
Durban, South Africa, 4110
Novartis Investigative Site
Durban, South Africa, 4030
Novartis Investigative Site
Gauteng, South Africa
Novartis Investigative Site
Johannesburg, South Africa, 2196
Novartis Investigative Site
Port Elizabeth, South Africa, 6001
Novartis Investigative Site
Pretoria, South Africa, 0002
Spain
Novartis Investigative Site
Cadiz, Andalucia, Spain, 11010
Novartis Investigative Site
Granada, Andalucia, Spain, 18014
Novartis Investigative Site
Jerez de La Frontera, Andalucia, Spain, 11407
Novartis Investigative Site
Malaga, Andalucia, Spain, 29010
Novartis Investigative Site
Malaga, Andalucia, Spain, 29018
Novartis Investigative Site
Málaga, Andalucia, Spain, 29010
Novartis Investigative Site
Puerto de Santa Maria, Andalucia, Spain, 11500
Novartis Investigative Site
Sanlúcar de Barrameda, Andalucia, Spain, 11540
Novartis Investigative Site
Sevilla, Andalucia, Spain, 41009
Novartis Investigative Site
Oviedo, Asturias, Spain, 33006
Novartis Investigative Site
Oviedo, Asturias, Spain, 33010
Novartis Investigative Site
Oviedo, Asturias, Spain, 33008
Novartis Investigative Site
Hospitalet de Llobregat, Barcelona, Spain, 08907
Novartis Investigative Site
Sabadell, Barcelona, Spain, 08208
Novartis Investigative Site
Alcazar de San Juan, Castilla la Mancha, Spain, 13600
Novartis Investigative Site
Aranda de Duero, Castilla y Leon, Spain, 09400
Novartis Investigative Site
Miranda de Ebro, Castilla y Leon, Spain, 09200
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08025
Novartis Investigative Site
Barcelona, Cataluña, Spain, 08905
Novartis Investigative Site
Barcelona, Cataluña, Spain, 08025
Novartis Investigative Site
Girona, Cataluña, Spain, 17007
Novartis Investigative Site
La Pobla Llarga, Cataluña, Spain, 46670
Novartis Investigative Site
Llança, Cataluña, Spain, 17490
Novartis Investigative Site
Manresa, Cataluña, Spain, 08240
Novartis Investigative Site
Mollet del Vallés, Cataluña, Spain, 08100
Novartis Investigative Site
Rubi, Cataluña, Spain, 08191
Novartis Investigative Site
Santa Coloma de Gramanet, Cataluña, Spain, 08923
Novartis Investigative Site
Tarrega, Cataluña, Spain, 25300
Novartis Investigative Site
Vic, Cataluña, Spain, 08500
Novartis Investigative Site
Alacuas, Comunidad Valenciana, Spain, 46970
Novartis Investigative Site
Alicante, Comunidad Valenciana, Spain, 03004
Novartis Investigative Site
Alzira, Comunidad Valenciana, Spain, 46600
Novartis Investigative Site
Benidorm, Comunidad Valenciana, Spain, 03550
Novartis Investigative Site
Puerto de Sagunto, Comunidad Valenciana, Spain, 46520
Novartis Investigative Site
Quart de Poblet, Comunidad Valenciana, Spain, 46930
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46011
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46017
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46014
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46019
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46010
Novartis Investigative Site
Xixona, Comunidad Valenciana, Spain, 03100
Novartis Investigative Site
Mérida, Extremadura, Spain, 06800
Novartis Investigative Site
Begonte, Galicia, Spain, 27373
Novartis Investigative Site
Ferrol, Galicia, Spain, 15405
Novartis Investigative Site
La Coruña, Galicia, Spain, 15010
Novartis Investigative Site
Pontevedra, Galicia, Spain, 36071
Novartis Investigative Site
Santiago de Compostela, Galicia, Spain, 15706
Novartis Investigative Site
Vigo, Galicia, Spain, 36200
Novartis Investigative Site
Palma De Mallorca, Islas Baleares, Spain
Novartis Investigative Site
Alcorcón, Madrid, Spain, 28922
Novartis Investigative Site
Arganda del Rey, Madrid, Spain, 28500
Novartis Investigative Site
Civdad Real, Madrid, Spain, 13002
Novartis Investigative Site
Murcia, Madrid, Spain, 30007
Novartis Investigative Site
Plentzia, Pais Vasco, Spain, 48620
Novartis Investigative Site
San Sebastian, Pais Vasco, Spain, 20014
Novartis Investigative Site
Villabona, Pais Vasco, Spain, 20150
Novartis Investigative Site
Zumarraga, Pais Vasco, Spain, 20700
Novartis Investigative Site
Alfaro, Rioja, Spain, 26540
Novartis Investigative Site
Logroño, Rioja, Spain, 26005
Novartis Investigative Site
Hospitalet de Llbregat, Spain, 08902
Novartis Investigative Site
Hospitalet de Llobregat, Spain
Novartis Investigative Site
Madrid, Spain, 28041
Novartis Investigative Site
Madrid, Spain, 28770
Novartis Investigative Site
Madrid, Spain, 28034
Novartis Investigative Site
Madrid, Spain, 28040
Novartis Investigative Site
Madrid, Spain, 28035
Novartis Investigative Site
Madrid, Spain, 28046
Sweden
Novartis Investigative Site
Göteborg, Sweden, SE-412 55
Novartis Investigative Site
Helsingborg, Sweden, 251 87
Novartis Investigative Site
Karlstad, Sweden, 651 85
Novartis Investigative Site
Malmö, Sweden, 21152
Novartis Investigative Site
Rättvik, Sweden, 79530
Novartis Investigative Site
Stenstorp, Sweden, SE-521 60
Novartis Investigative Site
Uppsala, Sweden, 751 85
Novartis Investigative Site
Varberg, Sweden, s-432 81
Switzerland
Novartis Investigative Site
Estavayer-le-Lac, CH, Switzerland, 1470
Novartis Investigative Site
Ascona, Switzerland
Novartis Investigative Site
Bern, Switzerland, 3010
Novartis Investigative Site
Bolligen, Switzerland, 3065
Novartis Investigative Site
Bruderholz, Switzerland, 4101
Novartis Investigative Site
Fribourg, Switzerland, 1700
Novartis Investigative Site
La Chaux-de-Fonds, Switzerland, 2300
Novartis Investigative Site
Lausanne, Switzerland, 1011
Novartis Investigative Site
Lugano, Switzerland, 6903
Novartis Investigative Site
Lugano, Switzerland, 6900
Novartis Investigative Site
Renens, Switzerland, 1020
Novartis Investigative Site
Schaffhausen, Switzerland, 8200
Novartis Investigative Site
St. Gallen, Switzerland, 9007
Novartis Investigative Site
Winterthur, Switzerland, 8400
Novartis Investigative Site
Zuerich, Switzerland, 8091
Taiwan
Novartis Investigative Site
Yungkang, Tainan, Taiwan, 710
Novartis Investigative Site
Changhua, Taiwan, 500
Novartis Investigative Site
Kaohsiung, Taiwan, 807
Novartis Investigative Site
Niaosong Township, Taiwan, 83301
Novartis Investigative Site
Taichung, Taiwan, 40705
Novartis Investigative Site
Taichung, Taiwan
Novartis Investigative Site
Taichung County, Taiwan
Novartis Investigative Site
Taipei, Taiwan, 114
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Taipei, Taiwan, 10002
Thailand
Novartis Investigative Site
Bangkok, Thailand, 10330
Novartis Investigative Site
Bangkok, Thailand, 10700
Novartis Investigative Site
Bangkok, Thailand, 10400
Novartis Investigative Site
Chiang Mai, Thailand, 50200
Turkey
Novartis Investigative Site
Altunizade, Turkey, 34662
Novartis Investigative Site
Ankara, Turkey, 06100
Novartis Investigative Site
Ankara, Turkey, 06590
Novartis Investigative Site
Gaziantep, Turkey, 27070
Novartis Investigative Site
Izmir, Turkey, 35340
Novartis Investigative Site
Izmir, Turkey, 35040
Novartis Investigative Site
Kocaeli, Turkey, 41380
United Kingdom
Novartis Investigative Site
High Wycombe, Buckinghamshire, United Kingdom, HP11 2TT
Novartis Investigative Site
Truro, Cornwall, United Kingdom, TR1 3LJ
Novartis Investigative Site
Paignton, Devon, United Kingdom, TQ4 5LA
Novartis Investigative Site
Cornwall, England, United Kingdom, PL23 1DT
Novartis Investigative Site
Welwyn Garden City,, Hertfordshire, United Kingdom, AL7 4HQ
Novartis Investigative Site
Gravesend, Kent, United Kingdom, DA1 24JW
Novartis Investigative Site
Glasgow, Scotland, United Kingdom, G12 8TA
Novartis Investigative Site
East Horsley, Surrey, United Kingdom, KT24 6QT
Novartis Investigative Site
Crawley, West Sussex, United Kingdom, RH10 7DX
Novartis Investigative Site
Bath, United Kingdom, BA2 3HT
Novartis Investigative Site
Cardiff, United Kingdom, CF5 4AD
Novartis Investigative Site
Cardiff, United Kingdom, CF14 4XN
Novartis Investigative Site
Glasgow, United Kingdom, G21 3UW
Novartis Investigative Site
Glasgow, United Kingdom, G11 6NT
Novartis Investigative Site
Irvine, United Kingdom, KA12 0AY
Novartis Investigative Site
Lancashire, United Kingdom, FY3 7EN
Novartis Investigative Site
Lancashire, United Kingdom, FY4 3AD
Novartis Investigative Site
London, United Kingdom, SW17 0QT
Novartis Investigative Site
London, United Kingdom, NW10 7NS
Novartis Investigative Site
London, United Kingdom, SE1 9RT
Novartis Investigative Site
Manchester, United Kingdom, M13 9NT
Novartis Investigative Site
Merseyside, United Kingdom, L7 8PX
Novartis Investigative Site
Rugby, United Kingdom, CV21 5 PX
Novartis Investigative Site
Vale of Glanmorgan, United Kingdom, CF63 4AR
Novartis Investigative Site
Wrexham, United Kingdom, LL13 7TD
Venezuela
Novartis Investigative Site
Caracas, Distrito Capital, Venezuela, 1020
Novartis Investigative Site
Caracas, Distrito Capital, Venezuela, 1040
Novartis Investigative Site
Caracas, Distrito Capital, Venezuela, 1080-A
Novartis Investigative Site
Caracas, Distrito Capital, Venezuela, 1010
Novartis Investigative Site
Caracas, Distrito Capital, Venezuela, 1100
Novartis Investigative Site
Puerto Ordaz, Estado Bolívar, Venezuela, 8050
Novartis Investigative Site
Valencia, Estado Carabobo, Venezuela, 2001
Novartis Investigative Site
Caracas, Estado Miranda, Venezuela, 1060
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Chair: Novartis Novartis
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00549757     History of Changes
Other Study ID Numbers: CSPP100E2337, 2007-000860-25
Study First Received: October 24, 2007
Results First Received: February 3, 2014
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: Ministry of Health
Canada: Health Canada
China: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Guatemala: Ministry of Public Health and Social Assistance
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Italy: National Institute of Health
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Portugal: National Pharmacy and Medicines Institute
Singapore: Center for Drug Administration
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
Taiwan: Department of Health
Thailand: Ministry of Public Health
Turkey: General Directorate of Pharmaceuticals and Pharmacy
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Venezuela: Ministry of Health and Social Development

Keywords provided by Novartis:
Type 2 diabetes mellitus
renal morbidity and mortality
cardiovascular disease
micro-albuminuria
macro-albuminuria
RAAS
renin inhibitor
Reduced estimated glomerular filtration rate

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014