Clinical Trial Search

Primary: Percentage of Participants With Growth Hormone (GH) and Insulin-like Growth Factor 1 (IGF-1) Observed Response by Dose Class — 20; 28.6; 14.3; 23.1 percentage of…

Primary: Acromegaly Quality of Life (ACROQoL) Global Score — 57; 60; 54 points on a scale

Primary: Percentage of Participants Diagnosed With Acromegaly — 5.8; 2.4 percentage of participants

Primary: Percentage of Patients With Relevant Reduction in Pituitary Tumour Volume (as Measured by MRI) From Baseline Volume (Visit 1) to Week 48 (After 12 Injections at Visit 5)…

Primary: Change in Liver Fat — 0.03 Lipid/water ratio

Primary: Change in High-sensitivity C-reactive Protein — 2.93; 3.23; -0.36; 1.64 mg/liter

Primary: Effect of Pegvisomant on Colon Tissue p53 Expression — 330.57 ng/mL

Primary: IGF-1 Level on Sandostatin LAR — 336; 186; 487 ng/mL — p=<0.05

Primary: IGF-1 Levels — 424 ng/mL — p=< 0.05

Primary: Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period — 57.9 percentage of subjects…

Primary: Percentage With Growth Hormone (GH) Suppression to < 0.4 ng/ml — 0; 7; 8 Participants

Primary: Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24) — -1.7; -2.1 µg/L

Primary: Total-group Response Rate at Month 3 — 18.2 Percentage of participants

Primary: The Number of Patients Who Achieve a Trough Human Growth Hormone (hGH) Concentration of <2.5µg/L During the Last 12 Hours of the 23 Hour Profile Following Each Study…

Primary: The Percentage of Participants With Complete Response (CR) at 8 Months — 25; 0; 9.4 percent

Primary: Participants With Trough Human Growth Hormone < 2.5 ug/mL — 1; 8; 4; 6 participants with trough hGH < 2.5 µg/mL

Primary: Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level — -0.034 ng/mL x ULN — p=0.6285

Primary: Percentage of Responders at the End of the Core Treatment Period — 86.9; 66.7; 40.4; 64.9 Percentage of responders

Primary: Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall — 14.6; 13.8; 15.1; 14.6 Percentage of…

Primary: Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 — 31.3; 19.2; 39.4; 21.8 Percentage of Participants — p=0.007

Primary: Height Standard Deviation Score — -2.52; -1.57; -1.19; -1.09 standard deviation score

Primary: Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1. — 15.4; 20.0; 0 percentage of participants…

Primary: The Percentage of Subjects or Their Partners That Are Competent to Self-administer Somatuline Autogel at the End of the Study, (Week 24/Early Termination), as Assessed…

Primary: Percent Change in Insulin-like Growth Factor I (IGF-1) From Baseline to Week 27 — -6.20; -7.16; -7.09 Percent change

Primary: Determination of the Maximum Tolerated Dose (MTD) by Number of Subjects With DLTs. — 0; 0; 0 participants

Primary: Standardised Mean Change From Baseline in Age-adjusted IGF-1 Levels at the EOST/EW Visit — -0.84; -0.52; 0.43; 0.59 SDS

Primary: Percentage of Subjects Having Maintained Their Injection Interval Schedule of Six Weeks or Increased Their Injection Interval to Eight Weeks Whilst Keeping Their…

Primary: Plasma Octreotide Level After Each Treatment Phase — 885; 1167 pg/mL — p=0.40

Primary: HsCRP — -1.1; 0.5; -1.3; -0.3 mg/L

Primary: Insulin Sensitivity — 3.06; 3.33 units on a scale