TriangleNCT01137682 · OUTCOME
Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- At 24 weeks
What was measured
The primary objective of this study was to compare the percentage of patients achieving biochemical control (defined as mean GH levels \<2.5 µg/L and normalization of sex- and age- adjusted IGF-1) at 24 weeks with pasireotide LAR 40 mg and pasireotide LAR 60 mg separately versus continued treatment with octreotide LAR 30 mg or lanreotide autogel (ATG) 120 mg. The primary efficacy variable is the proportion of patients with a reduction of mean GH levels to \< 2.5 µg/L and normalization of sex- and age-adjusted IGF-1 at 24 weeks.
Groups in this outcome
Pasireotide LAR 40 mg
Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
Pasireotide LAR 60 mg
Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
Control Arm (Octreotide or Lanreotide)
Open label octreotide LAR 30 mg or lanreotide ATG 120 mg supplied either locally or from designated depot. Administered intramuscular every 28 days
| Group | Source count |
|---|---|
| Pasireotide LAR 40 mg | 65 |
| Pasireotide LAR 60 mg | 65 |
| Control Arm (Octreotide or Lanreotide) | 68 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pasireotide LAR 40 mg | 15.4 | Not reported | 7.63 | 26.48 | Not reported |
| Pasireotide LAR 60 mg | 20.0 | Not reported | 11.10 | 31.77 | Not reported |
| Control Arm (Octreotide or Lanreotide) | 0 | Not reported | 0 | 5.28 | Not reported |
Source statistical analyses
- ci Lower Limit
- 3.32
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit Comment
- infinity
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0006
- param Type
- Odds Ratio (OR)
- param Value
- 16.63
- statistical Comment
- An exact logistic regression model that adjusts for the randomization stratification factors was used to test the null hypothesis.
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 4.72
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit Comment
- infinity
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 23.03
- statistical Comment
- An exact logistic regression model that adjusts for the randomization stratification factors was used to test the null hypothesis.
- statistical Method
- Regression, Logistic
Complete source fields
- analyses
- ci Lower Limit
- 3.32
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit Comment
- infinity
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0006
- param Type
- Odds Ratio (OR)
- param Value
- 16.63
- statistical Comment
- An exact logistic regression model that adjusts for the randomization stratification factors was used to test the null hypothesis.
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 4.72
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit Comment
- infinity
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 23.03
- statistical Comment
- An exact logistic regression model that adjusts for the randomization stratification factors was used to test the null hypothesis.
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.63
- upper Limit
- 26.48
- value
- 15.4
- group Id
- OG001
- lower Limit
- 11.10
- upper Limit
- 31.77
- value
- 20.0
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 5.28
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 65
- group Id
- OG002
- value
- 68
- units
- Participants
- description
- The primary objective of this study was to compare the percentage of patients achieving biochemical control (defined as mean GH levels \<2.5 µg/L and normalization of sex- and age- adjusted IGF-1) at 24 weeks with pasireotide LAR 40 mg and pasireotide LAR 60 mg separately versus continued treatment with octreotide LAR 30 mg or lanreotide autogel (ATG) 120 mg. The primary efficacy variable is the proportion of patients with a reduction of mean GH levels to \< 2.5 µg/L and normalization of sex- and age-adjusted IGF-1 at 24 weeks.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
- id
- OG000
- title
- Pasireotide LAR 40 mg
- description
- Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
- id
- OG001
- title
- Pasireotide LAR 60 mg
- description
- Open label octreotide LAR 30 mg or lanreotide ATG 120 mg supplied either locally or from designated depot. Administered intramuscular every 28 days
- id
- OG002
- title
- Control Arm (Octreotide or Lanreotide)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- At 24 weeks
- title
- Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1.
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice