Completed

A Multicenter, Open-label, Randomized, Phase II Study to Evaluate Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Pasireotide LAR in Japanese Patients With Active Acromegaly or Pituitary Gigantism

What is being tested

Pasireotide LAR

+ Pasireotide LAR

Drug

Who is being recruted

Bone Diseases+22

+ Bone Diseases, Developmental

+ Bone Diseases, Endocrine

Over 18 Years

+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: October 2012

See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals

Last updated: September 16, 2019

Sourced from a government-validated database.Claim as a partner

Study start date: October 16, 2012

Actual date on which the first participant was enrolled.

To evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of pasireotide LAR in Japanese patients with active acromegaly or pituitary gigantism. Primary objective was to assess the total-group efficacy of pasireotide LAR on the reduction of mean GH levels to < 2.5 µg/L and the normalization of insulin-like growth factor-1 (IGF-1) at 3 months of study treatment.

NCT01673646

Principal SponsorNovartis Pharmaceuticals

Last updated: September 16, 2019

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

33 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone DiseasesBone Diseases, DevelopmentalBone Diseases, EndocrineBrain DiseasesBrain NeoplasmsCentral Nervous System DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsHyperpituitarismHypothalamic DiseasesHypothalamic NeoplasmsMusculoskeletal DiseasesNeoplasmsNeoplasms by SiteNervous System DiseasesNervous System NeoplasmsPathologic ProcessesPituitary DiseasesPathological Conditions, Signs and SymptomsSupratentorial NeoplasmsCentral Nervous System NeoplasmsAcromegalyGigantismGrowth DisordersPituitary Neoplasms

Criteria

2 inclusion criteria required to participate

Patients with inadequately controlled acromegaly or pituitary gigantism

Patients with medication naïve acromegaly or pituitary gigantism

3 exclusion criteria prevent from participating

Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1c > 8%

Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment

Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF > 470 ms, hypokalemia, hypomagnesemia, hypocalcemia, family history of long QT syndrome, or patients receiving a concomitant medication known to prolong QT interval

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Enrolled patients were randomized to 20mg pasireotide LAR.

Group II

Experimental

Enrolled patients were randomized to 40mg pasireotide LAR.

Group III

Experimental

Enrolled patients were randomized to 60mg pasireotide LAR.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 27 locations

Novartis Investigative Site

Nagoya, JapanOpen Novartis Investigative Site in Google Maps

Novartis Investigative Site

Toyoake, Japan

Novartis Investigative Site

Fukuoka, Japan

Novartis Investigative Site

Kitakyushu, Japan

Completed27 Study Centers