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Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

Primary Purpose

Acromegaly

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Pasireotide

Octreotide

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring Acromegaly,, adult,, growth hormone,, insulin-like growth factor I,, somatostatin analogue

Eligibility Criteria

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

Inclusion criteria:

Patients with active acromegaly (based on elevated GH and IGF-1 levels)
Patients who have undergone one or more pituitary surgeries, but have not been treated medically, or de-novo patients presenting a visible pituitary adenoma on MRI and who refuse pituitary surgery or for whom pituitary surgery is contraindicated
Patients for whom written informed consent to participate in the study has been obtained prior to any study related activity

Exclusion criteria:

Patients who are being or were treated with octreotide, lanreotide, dopamine agonists or GH antagonists with the exception of a single dose of short-acting octrotide or short-acting dopamine agonists. In case of a single dose of short-acting octrotide, the dose should not be used to predict the response to the octretide treatment. The single dose of short-acting octreotide or short-acting dopamine agonists should not be administered in the 3 days prior to randomization
Patients with compression of the optic chiasm causing any visual field defect
Patients who have received pituitary irradiation within the last ten years prior to visit 1
Poorly controlled diabetic patients

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

Cedars Sinai Medical Center The Pituitary Center
University of California at Los Angeles Division of Endocrinology
Stanford University Medical Center Stanford Cancer Center (3)
University of Florida SC
Johns Hopkins University School of Medicine Dept.ofJohnsHopkinsUniv.
University of Michigan Comprehensive Cancer Center Deptof Endocrinology&Diabetes
Columbia University Medical Center- New York Presbyterian Dept. of CU Collegeof Phys&Sur
Northport VA Medical Center CSOM230C2305
Oregon Health & Sciences University DeptofOregonHealth&Sciences(3)
Allegheny Endocrinology Associates
University of Texas Southwestern Medical Center Danziger Research Bldg.
University of Texas/MD Anderson Cancer Center Regulatory -12
Baylor College of Medicine
Swedish Medical Center Dept.ofSeattle Neuroscience(2)
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pasireotide LAR

Octreotide LAR

Arm Description

Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 20 or 60 mg, respectively. Patients who responded to Pasireotide LAR (i.e. the randomized treatment) at the end of the core (Month 12), continued Pasireotide LAR treatment in the extension. Patients who did not respond to Pasireotide LAR at the end of the core (Month 12) were allowed to switch to receive Octreotide LAR in the extension.

Patients in this arm received Octreotide LAR 20 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 10 or 30 mg, respectively. Patients who responded to Octreotide LAR (i.e. the randomized treatment) at the end of the core (Month 12) continued Octreotide LAR treatment in the extension (up to 2 years of treatment). Patients who did not respond to Octreotide LAR at the end of the core (Month 12) were allowed to switch to receive Pasireotide LAR in the extension.

Outcomes

Primary Outcome Measures

Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1

Percentage of participants with a reduction of mean GH levels to <2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1. Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.

Secondary Outcome Measures

Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L

Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile). Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.

Change From Baseline in Tumor Volume at 12 Months

Absolute and percentage change from baseline in tumor volume (assessed by pituitary MRI) Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.

Percentage of Participants With Normalization of IGF-1

Percentage of participants with normalization of sex- and age-adjusted IGF-1. Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.

Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1

Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1. Denominator for time points up to Month 12 is the Full Analysis Set (FAS). Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover. Analysis was based on data up to crossover (i.e., included data from both blinded core & ext. phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included.)

Summary of Mean GH Values

Mean GH levels (based on a 5-point profile over 2 hours). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).

Time to First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 (No. of Responders: Pasireotite LAR = 81, Octreotide LAR = 63) )

Time to first response for patients achieving a reduction of mean GH level to < 2.5 μg/L and normalization of IGF-1. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).

Severity Scores of Acromegaly Symptoms

Severity scores of acromegaly symptoms (Headache, Fatigue, Perspiration, Paresthesias, Osteoarthralgia). Symptoms were scored from 0 (no symptom) to 4 (very severe). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).

Ring Size

Ring size (based on jeweler's finger gauge). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).

Health-related Quality-of-life as Measured by the AcroQoL Questionnaire

Acromegalyy quality of life (AcroQoL) total scores. The AcroQoL questionnaire is unidimensional and contains 22 items divided in two scales: one that evaluates physical aspects (eight items) and another one that evaluates psychological aspects (14 items). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).

Summary of Prolactin Levels

Prolactin Levels. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).

Duration of Response for Patients Achieving a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 at Month 12 (No. of Responders: Pasireotide LAR = 51, Octreotide LAR = 32)

The duration of response is defined as the time from the date that patient first met and maintained the response criteria based on primary efficacy variable to the date that patient lost response status. Median and corresponding 95% CI are derived based on Kaplan-Meier method. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).

Pasireotide Trough Concentrations by Incident Dose

Pasireotide LAR trough concentrations by incident dose (last dose administered prior to PK sample collection). PK observations with missing concentrations, missing dose, missing elapsed time or an elapsed time from previous injection outside of 28±2 days window were excluded. 5 patients with evaluable PK data in the pasireotide arm received erroneously 20 mg pasireotide LAR at baseline.

Octreotide Trough Concentrations by Incident Dose

Octreotide LAR trough concentrations by incident dose (last dose administered prior to PK sample collection). PK observations with missing concentrations, missing dose, missing elapsed time or an elapsed time from previous injection outside of 28±2 days window were excluded.

Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 After Crossover

Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).

Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L

Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included). Denominator for time points up to Month 12 is the Full Analysis Set. Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover.

Percentage of Participants With Normalization of IGF-1

Percentage of participants with normalization of sex- and age-adjusted IGF-1. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included). Denominator for time points up to Month 12 is the FAS. Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover.

Change From Baseline in Tumor Volume

Percentage change from baseline in tumor volume (assessed by pituitary MRI). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).

Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L After Crossover

Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile). Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).

Percentage of Participants With Normalization of IGF-1 After Crossover

Percentage of participants with normalization of sex- and age-adjusted IGF-1. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).

Summary of Mean GH Values After Crossover

Mean GH levels (based on a 5-point profile over 2 hours). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over).

Change From Extension Baseline in Tumor Volume After Crossover

Percentage change from extension baseline in tumor volume (assessed by pituitary MRI). Extension baseline was defined as last assessment prior to the administration of the new treatment after crossover. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over).

Severity Scores of Acromegaly Symptoms After Crossover

Severity scores of acromegaly symptoms (Headache, Fatigue, Perspiration, Paresthesias, Osteoarthralgia). Symptoms were scored from 0 (no symptom) to 4 (very severe). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over).

Ring Size After Crossover

Ring size (based on jeweler's finger gauge). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). BL = baseline, LH = left hand, RH = right hand, CO = crossover

Health-related Quality-of-life as Measured by the AcroQoL Questionnaire After Crossover

AcroQoL total scores. The AcroQoL questionnaire is unidimensional and contains 22 items divided in two scales: one that evaluates physical aspects (eight items) and another one that evaluates psychological aspects (14 items). The scoring of the questionnaire was performed as specified by the instrument developers. Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Total scores range from 0 to 100. Higher scores represent better quality of life.

Summary of Prolactin Levels After Crossover

Prolactin (PRL) levels. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Extension baseline was defined as last measurement prior to the start of crossover treatment.

Full Information

NCT ID

NCT00600886

First Posted

January 14, 2008

Last Updated

June 5, 2017

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00600886

Brief Title

Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

Official Title

A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

February 11, 2008 (Actual)

Primary Completion Date

March 11, 2016 (Actual)

Study Completion Date

March 11, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment. The objective of this study was to compare the proportion of patients with a reduction of mean GH level to <2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months. Following one year of treatment patients could proceed into the study extension. Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) were switched to the other treatment arm at month 13.

6. Conditions and Keywords

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

Acromegaly

Keywords

Acromegaly,, adult,, growth hormone,, insulin-like growth factor I,, somatostatin analogue

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

358 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pasireotide LAR

Arm Type

Experimental

Arm Description

Arm Title

Octreotide LAR

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Pasireotide

Other Intervention Name(s)

SOM230

Intervention Description

Pasireotide LAR - intramuscular (i.m.) depot injection given once every 28 days.

Intervention Type

Drug

Intervention Name(s)

Octreotide

Intervention Description

Octreotide LAR - i.m. depot injection given once every 28 days.

Primary Outcome Measure Information:

Title

Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L

Description

Time Frame

12 Months

Title

Change From Baseline in Tumor Volume at 12 Months

Description

Time Frame

Baseline, 12 Months

Title

Percentage of Participants With Normalization of IGF-1

Description

Time Frame

12 Months

Title

Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1

Description

Time Frame

Months 3, 6, 9, 12, 16, 19, 22, 25

Title

Summary of Mean GH Values

Description

Time Frame

Baseline, Months 3, 6, 9, 12, 16, 19, 22, 25

Title

Time to First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 (No. of Responders: Pasireotite LAR = 81, Octreotide LAR = 63) )

Description

Time Frame

Up to 26 months

Title

Severity Scores of Acromegaly Symptoms

Description

Time Frame

Baseline, Months 12, 25

Title

Ring Size

Description

Time Frame

Baseline, Months 12, 25

Title

Health-related Quality-of-life as Measured by the AcroQoL Questionnaire

Description

Time Frame

Baseline, Months 12, 25

Title

Summary of Prolactin Levels

Description

Time Frame

Baseline, Months 12, 25

Title

Duration of Response for Patients Achieving a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 at Month 12 (No. of Responders: Pasireotide LAR = 51, Octreotide LAR = 32)

Description

Time Frame

Up to 26 months

Title

Pasireotide Trough Concentrations by Incident Dose

Description

Time Frame

Months 1 - 12

Title

Octreotide Trough Concentrations by Incident Dose

Description

Time Frame

Months 1 - 12

Title

Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 After Crossover

Description

Time Frame

Months 3, 6, 9, 12 after crossover

Title

Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L

Description

Time Frame

Months 3, 6, 9, 12, 16, 19, 22, 25

Title

Percentage of Participants With Normalization of IGF-1

Description

Time Frame

Months 3, 6, 9, 12, 16, 19, 22, 25

Title

Change From Baseline in Tumor Volume

Description

Time Frame

Baseline, months 6, 12, 19, 25

Title

Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L After Crossover

Description

Time Frame

Months 3, 6, 9, 12 after crossover

Title

Percentage of Participants With Normalization of IGF-1 After Crossover

Description

Time Frame

Months 3, 6, 9, 12 after crossover

Title

Summary of Mean GH Values After Crossover

Description

Time Frame

Extension baseline, months 3, 6, 9, 12 after crossover

Title

Change From Extension Baseline in Tumor Volume After Crossover

Description

Time Frame

Extension baseline, months 6, 12 after crossover

Title

Severity Scores of Acromegaly Symptoms After Crossover

Description

Time Frame

Extension baseline, month 12 after crossover

Title

Ring Size After Crossover

Description

Time Frame

Extension baseline, month 12 after crossover

Title

Health-related Quality-of-life as Measured by the AcroQoL Questionnaire After Crossover

Description

Time Frame

Extension baseline, months 12 after crossover

Title

Summary of Prolactin Levels After Crossover

Description

Time Frame

Extension baseline, month 12 after crossover

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Patients with active acromegaly (based on elevated GH and IGF-1 levels) Patients who have undergone one or more pituitary surgeries, but have not been treated medically, or de-novo patients presenting a visible pituitary adenoma on MRI and who refuse pituitary surgery or for whom pituitary surgery is contraindicated Patients for whom written informed consent to participate in the study has been obtained prior to any study related activity Exclusion criteria: Patients who are being or were treated with octreotide, lanreotide, dopamine agonists or GH antagonists with the exception of a single dose of short-acting octrotide or short-acting dopamine agonists. In case of a single dose of short-acting octrotide, the dose should not be used to predict the response to the octretide treatment. The single dose of short-acting octreotide or short-acting dopamine agonists should not be administered in the 3 days prior to randomization Patients with compression of the optic chiasm causing any visual field defect Patients who have received pituitary irradiation within the last ten years prior to visit 1 Poorly controlled diabetic patients Other protocol-defined inclusion/exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Novartis

Organizational Affiliation

Novartis

Official's Role

Study Chair

Facility Information:

Facility Name

Cedars Sinai Medical Center The Pituitary Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

University of California at Los Angeles Division of Endocrinology

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Stanford University Medical Center Stanford Cancer Center (3)

City

Stanford

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

University of Florida SC

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

Johns Hopkins University School of Medicine Dept.ofJohnsHopkinsUniv.

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Facility Name

University of Michigan Comprehensive Cancer Center Deptof Endocrinology&Diabetes

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-0944

Country

United States

Facility Name

Columbia University Medical Center- New York Presbyterian Dept. of CU Collegeof Phys&Sur

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Northport VA Medical Center CSOM230C2305

City

Northport

State/Province

New York

ZIP/Postal Code

11768

Country

United States

Facility Name

Oregon Health & Sciences University DeptofOregonHealth&Sciences(3)

City

Portland

State/Province

Oregon

ZIP/Postal Code

97201

Country

United States

Facility Name

Allegheny Endocrinology Associates

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Facility Name

University of Texas Southwestern Medical Center Danziger Research Bldg.

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

University of Texas/MD Anderson Cancer Center Regulatory -12

City

Houston

State/Province

Texas

ZIP/Postal Code

77030-4009

Country

United States

Facility Name

Baylor College of Medicine

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Swedish Medical Center Dept.ofSeattle Neuroscience(2)

City

Seattle

State/Province

Washington

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1405BCH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

1425EKP

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1232AAC

Country

Argentina

Facility Name

Novartis Investigative Site

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Fortaleza

State/Province

ZIP/Postal Code

60430 370

Country

Brazil

Facility Name

Novartis Investigative Site

City

Brasilia

State/Province

ZIP/Postal Code

70840-901

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Luis

State/Province

ZIP/Postal Code

65020-070

Country

Brazil

Facility Name

Novartis Investigative Site

City

Curitiba

State/Province

ZIP/Postal Code

80060-900

Country

Brazil

Facility Name

Novartis Investigative Site

City

Rio de Janeiro

State/Province

ZIP/Postal Code

21941-913

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

ZIP/Postal Code

05403-000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

Novartis Investigative Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Novartis Investigative Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 2W5

Country

Canada

Facility Name

Novartis Investigative Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Novartis Investigative Site

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200025

Country

China

Facility Name

Novartis Investigative Site

City

Bogota

State/Province

Cundinamarca

ZIP/Postal Code

111411

Country

Colombia

Facility Name

Novartis Investigative Site

City

Prague 2

State/Province

Czech republic

ZIP/Postal Code

128 02

Country

Czechia

Facility Name

Novartis Investigative Site

City

Aalborg

ZIP/Postal Code

DK-9100

Country

Denmark

Facility Name

Novartis Investigative Site

City

Copenhagen

ZIP/Postal Code

DK-2100

Country

Denmark

Facility Name

Novartis Investigative Site

City

Bois Guillaume Cedex

ZIP/Postal Code

76233

Country

France

Facility Name

Novartis Investigative Site

City

Bron Cedex

ZIP/Postal Code

69677

Country

France

Facility Name

Novartis Investigative Site

City

Le Kremlin Bicetre

ZIP/Postal Code

94275

Country

France

Facility Name

Novartis Investigative Site

City

Marseille cedex 05

ZIP/Postal Code

13385

Country

France

Facility Name

Novartis Investigative Site

City

Montpellier Cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

Novartis Investigative Site

City

Pessac Cedex

ZIP/Postal Code

33604

Country

France

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10098

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

Novartis Investigative Site

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45122

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

80336

Country

Germany

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Pireas

ZIP/Postal Code

18537

Country

Greece

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1085

Country

Hungary

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Novartis Investigative Site

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Novartis Investigative Site

City

Cona

State/Province

ZIP/Postal Code

44100

Country

Italy

Facility Name

Novartis Investigative Site

City

Genova

State/Province

ZIP/Postal Code

16132

Country

Italy

Facility Name

Novartis Investigative Site

City

Padova

State/Province

ZIP/Postal Code

35128

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

State/Province

ZIP/Postal Code

56124

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00168

Country

Italy

Facility Name

Novartis Investigative Site

City

Torino

State/Province

ZIP/Postal Code

10126

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

130-872

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

06726

Country

Mexico

Facility Name

Novartis Investigative Site

City

México

State/Province

Distrito Federal

ZIP/Postal Code

06720

Country

Mexico

Facility Name

Novartis Investigative Site

City

Nijmegen

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Bergen

ZIP/Postal Code

NO-5021

Country

Norway

Facility Name

Novartis Investigative Site

City

Oslo

ZIP/Postal Code

NO-0379

Country

Norway

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

31-531

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

01 809

Country

Poland

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

117036

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

119992

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

197341

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint-Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41013

Country

Spain

Facility Name

Novartis Investigative Site

City

Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novartis Investigative Site

City

Alicante

State/Province

Comunidad Valenciana

ZIP/Postal Code

03010

Country

Spain

Facility Name

Novartis Investigative Site

City

Santiago de Compostela

State/Province

Galicia

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novartis Investigative Site

City

Linkoping

ZIP/Postal Code

SE-581 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Malmö

ZIP/Postal Code

SE-205 02

Country

Sweden

Facility Name

Novartis Investigative Site

City

Uppsala

ZIP/Postal Code

SE-751 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

St. Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Lin-Kou

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Erzurum

ZIP/Postal Code

25240

Country

Turkey

Facility Name

Novartis Investigative Site

City

Leeds

ZIP/Postal Code

LS1 3EX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Liverpool

ZIP/Postal Code

L7 8XP

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

27039081

Citation

Bronstein MD, Fleseriu M, Neggers S, Colao A, Sheppard M, Gu F, Shen CC, Gadelha M, Farrall AJ, Hermosillo Resendiz K, Ruffin M, Chen Y, Freda P; Pasireotide C2305 Study Group. Switching patients with acromegaly from octreotide to pasireotide improves biochemical control: crossover extension to a randomized, double-blind, Phase III study. BMC Endocr Disord. 2016 Apr 2;16:16. doi: 10.1186/s12902-016-0096-8.

Results Reference

derived

PubMed Identifier

26437217

Citation

Shanik MH, Cao PD, Ludlam WH. HISTORICAL RESPONSE RATES OF SOMATOSTATIN ANALOGUES IN THE TREATMENT OF ACROMEGALY: A SYSTEMATIC REVIEW. Endocr Pract. 2016 Mar;22(3):350-6. doi: 10.4158/EP15913.RA. Epub 2015 Oct 5.

Results Reference

derived

PubMed Identifier

25103549

Citation

Sheppard M, Bronstein MD, Freda P, Serri O, De Marinis L, Naves L, Rozhinskaya L, Hermosillo Resendiz K, Ruffin M, Chen Y, Colao A. Pasireotide LAR maintains inhibition of GH and IGF-1 in patients with acromegaly for up to 25 months: results from the blinded extension phase of a randomized, double-blind, multicenter, Phase III study. Pituitary. 2015 Jun;18(3):385-94. doi: 10.1007/s11102-014-0585-6. Erratum In: Pituitary. 2015 Jun;18(3):395-6.

Results Reference

derived

Links:

URL

http://www.novartisclinicaltrials.com/webapp/etrials/searchTrial.do?trialID=660

Description

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Learn more about this trial

Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

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