A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly
The patients will receive either Pasireotide LAR or Octreotide LAR for one year of treatment. The objective of this study is 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 may proceed into the study extension. Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) will be switched to the other treatment arm at month 13.
NCT00600886 — Acromegaly
Status: Active, not recruiting
http://inclinicaltrials.com/acromegaly/NCT00600886/
Changes of Left Ventricular Mass and Cardiac Function in Patients With Active Acromegaly During Treatment With the Growth Hormone Receptor Antagonist Pegvisomant: an Open-labelled, Prospective Study
The purpose of this study is to evaluate changes in left ventricular mass and cardiac function in patients with active acromegaly before and after treatment with the growth hormone receptor antagonist pegvisomant for one year.
NCT00552851 — Heart Failure
Status: Recruiting
http://inclinicaltrials.com/heart-failure/NCT00552851/
A Phase I, Multicenter, Open-label, Randomized Study Assessing the Pharmacokinetics, Safety, and Tolerability of Monthly Doses of Pasireotide i.m. LAR Injection in Patients With Acromegaly and Patients With Carcinoid Disease
This study will assess the pharmacokinetic profile and the safety/tolerability profile of single and monthly doses of pasireotide LAR intramuscular (i.m.) injection in patients with acromegaly and patients with carcinoid disease
NCT00446082 — Acromegaly
Status: Completed
http://inclinicaltrials.com/acromegaly/NCT00446082/
A Phase III, Multicentre, Open Label, Comparative, Dose-interval Titration Study Evaluating the Efficacy and Safety of Six Repeated Deep Subcutaneous Administrations of Lanreotide Autogel 120mg, in Acromegalic Patients Previously Treated With Octreotide LAR
A multicentre, prospective, open label study of acromegalic patients evaluating the efficacy and safety of different dose-intervals of Lanreotide Autogel 120mg according to international standards and compared to previous treatment with Octreotide LAR 10, 20 or 30 mg.
NCT00444873 — Acromegaly
Status: Completed
http://inclinicaltrials.com/acromegaly/NCT00444873/
Open Label Study Assessing the Efficacy and Safety of Octreotide Acetate in Patients With Acromegaly, With Micro or Macroadenomas
The purpose of this study is to evaluate the efficacy of octreotide acetate to decrease GH and IGF-I levels in acromegalic patients, with microadenomas (≤ 10 mm) or macroadenomas (> 10 mm).
NCT00242541 — Acromegaly
Status: Terminated
http://inclinicaltrials.com/acromegaly/NCT00242541/
A Multicentre Prospective Controlled Observer Blinded Cohort Study in Patients With Acromegaly to Evaluate the Risk of Cardiac Valvular Regurgitation in Patients Treated With Lanreotide Relative to Patients Treated With Octreotide
The aim of the study is to compare the risk of acromegaly patients developing valvular regurgitation when receiving lanreotide or octreotide
NCT00234520 — Acromegaly
Status: Completed
http://inclinicaltrials.com/acromegaly/NCT00234520/
Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly
Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. The objective of this study is to assess the safety and efficacy of long-acting repeatable formulation of octreotide and to compare it to the safety and efficacy of surgery in patients with acromegaly who have not had any previous treatment for acromegaly.
NCT00225979 — Acromegaly
Status: Completed
http://inclinicaltrials.com/acromegaly/NCT00225979/
Effects of Physiologic Growth Hormone Administration on Cardiovascular Risk in Subjects With Growth Hormone Deficiency Following Cure of Acromegaly
The purpose of the study is to evaluate the effects of growth hormone (GH) replacement in men and women with a history of acromegaly and who are now growth hormone deficient. We will compare them to persons with a history of acromegaly who have normal GH levels. Acromegaly results when an area in the brain, called the pituitary, produces too much growth hormone. When an individual is cured of acromegaly, the growth hormone levels may be normal or low (that is GH deficiency). Growth hormone deficiency means the body no longer produces as much growth hormone because the pituitary/hypothalamic region was damaged by a tumor or by treatment received. We will study the effects of growth hormone replacement on the health of the heart and blood vessels of GH deficient persons by looking to see if this therapy: 1. has effects on cardiovascular risk markers (special blood tests which indicate how healthy your heart and arteries are) 2. affects the stiffness of the arteries 3. affects your heart rate and the capacity of your heart to respond to changes in body position 4. has different effects depending on whether you are taking estrogen / testosterone. We will assess these measures of health on one occasion in persons with cured acromegaly and normal GH levels and in persons with cured acromegaly who have GH deficiency and a contraindication to receiving GH. GH deficient individuals with no contraindication to receiving GH, will participate in the study for 12 months. Individuals with normal GH levels, or who are GH deficient and have a contraindication to receiving GH, will be asked to return for one more visit (without any interventions).
NCT00182091 — Acromegaly
Status: Completed
http://inclinicaltrials.com/acromegaly/NCT00182091/
Extension to a Multi-Center, Randomized, Crossover, Open Label, Dose Finding Study to Compare the Safety, Efficacy, and Pharmacokinetics/Pharmacodynamics (PK/PD) Relationship of Multiple Doses of Pasireotide (SOM230) (200, 400, and 600 μg Bid) and Doses of Open Label Sandostatin® (SMS) (100 μg Tid) in Acromegalic Patients
Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth hormone (GH), generally caused by a GH-secreting pituitary adenoma. The study assessed the long-term safety and efficacy of pasireotide in participants with acromegaly.
NCT00171730 — Acromegaly
Status: Completed
http://inclinicaltrials.com/acromegaly/NCT00171730/
Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction - A Twelve Month Randomized Cross-Over Study in Patients With Acromegaly
The morbidity and the mortality in acromegalic patients closely correspond to growth hormone (GH) levels and therefore efficient long-term treatment is important. Neurosurgery is the first choice of treatment in acromegalic patients. Surgery normalizes GH levels in about 80% of patients with microadenomas, but less than 50 % of patients with macroadenomas respond sufficiently to surgery alone. In most patients, additional medical therapy is therefore needed. Somatostatin analogues have successfully been used in treatment of acromegaly if surgery or radiotherapy can not lead to normal GH and IGF-I levels. Lanreotide Autogel (LAN) is a new formulation of lanreotide consisting of a prolonged release aqueous formulation, which can be injected intramuscularly or deep subcutaneously once every 28 days. Aim The aim of the present study was to compare the efficacy of OCT and LAN in obtaining GH and IGF-I levels according to the 2000 Consensus. Furthermore, we wanted to evaluate which treatment modality resulted in the lowest possible IGF-I and GH levels and the highest patient satisfaction.
NCT00145405 — Acromegaly
Status: Completed
http://inclinicaltrials.com/acromegaly/NCT00145405/