TriangleNCT01064310 · OUTCOME
Change From Baseline (BL) in Systolic Blood Pressure (SBP) and Diastolic BP (DBP)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Millimeters of mercury (mmHg)
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline of Period (P) 1 (Screening); Period 1 Weeks 2 and 6 (Study Weeks 2 and 6); Baseline of Period 2 (Washout=Study Week 12); Period 2 Weeks 2, 6, and 10 (Study Weeks 14, 18, and 22)
What was measured
When the heart beats, it contracts and pushes blood through the arteries to the rest of body. This force creates pressure on the arteries called SBP. DBP is the pressure in the arteries when the heart rests between beats. Normal levels: SBP (120 mmHg or less); DBP (80 mmHg or less). Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.
Analysis population: Safety-Randomized Study Population. All participants who received sunitinib or pazopanib either during Period 1 or Period 2 were counted in both treatment groups (sunitinib and pazopanib). Only those participants contributing data at the indicated time points were evaluated.
Groups in this outcome
Sunitinib
Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
Pazopanib
Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
| Group | Source count |
|---|---|
| Sunitinib | 139 |
| Pazopanib | 147 |
Reported measurements
SBP, Week 2; n=139, 147
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib | 6.3 | 15.26 | Not reported | Not reported | Not reported |
| Pazopanib | 7.5 | 16.36 | Not reported | Not reported | Not reported |
SBP, Week 6; n=109, 134
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib | -0.4 | 18.65 | Not reported | Not reported | Not reported |
| Pazopanib | 7.5 | 17.21 | Not reported | Not reported | Not reported |
SBP, Week 10; n=61, 64
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib | 4.5 | 18.43 | Not reported | Not reported | Not reported |
| Pazopanib | 4.7 | 20.45 | Not reported | Not reported | Not reported |
DBP, Week 2; n=139, 147
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib | 6.5 | 9.91 | Not reported | Not reported | Not reported |
| Pazopanib | 6.5 | 10.49 | Not reported | Not reported | Not reported |
DBP, Week 6; n=109, 134
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib | -0.4 | 9.48 | Not reported | Not reported | Not reported |
| Pazopanib | 6.9 | 10.87 | Not reported | Not reported | Not reported |
DBP, Week 10; n=61, 64
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib | 3.1 | 10.69 | Not reported | Not reported | Not reported |
| Pazopanib | 5.6 | 11.44 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 15.26
- value
- 6.3
- group Id
- OG001
- spread
- 16.36
- value
- 7.5
- title
- SBP, Week 2; n=139, 147
- categories
- measurements
- group Id
- OG000
- spread
- 18.65
- value
- -0.4
- group Id
- OG001
- spread
- 17.21
- value
- 7.5
- title
- SBP, Week 6; n=109, 134
- categories
- measurements
- group Id
- OG000
- spread
- 18.43
- value
- 4.5
- group Id
- OG001
- spread
- 20.45
- value
- 4.7
- title
- SBP, Week 10; n=61, 64
- categories
- measurements
- group Id
- OG000
- spread
- 9.91
- value
- 6.5
- group Id
- OG001
- spread
- 10.49
- value
- 6.5
- title
- DBP, Week 2; n=139, 147
- categories
- measurements
- group Id
- OG000
- spread
- 9.48
- value
- -0.4
- group Id
- OG001
- spread
- 10.87
- value
- 6.9
- title
- DBP, Week 6; n=109, 134
- categories
- measurements
- group Id
- OG000
- spread
- 10.69
- value
- 3.1
- group Id
- OG001
- spread
- 11.44
- value
- 5.6
- title
- DBP, Week 10; n=61, 64
- denoms
- counts
- group Id
- OG000
- value
- 139
- group Id
- OG001
- value
- 147
- units
- Participants
- description
- When the heart beats, it contracts and pushes blood through the arteries to the rest of body. This force creates pressure on the arteries called SBP. DBP is the pressure in the arteries when the heart rests between beats. Normal levels: SBP (120 mmHg or less); DBP (80 mmHg or less). Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
- id
- OG000
- title
- Sunitinib
- description
- Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
- id
- OG001
- title
- Pazopanib
- param Type
- MEAN
- population Description
- Safety-Randomized Study Population. All participants who received sunitinib or pazopanib either during Period 1 or Period 2 were counted in both treatment groups (sunitinib and pazopanib). Only those participants contributing data at the indicated time points were evaluated.
- reporting Status
- POSTED
- time Frame
- Baseline of Period (P) 1 (Screening); Period 1 Weeks 2 and 6 (Study Weeks 2 and 6); Baseline of Period 2 (Washout=Study Week 12); Period 2 Weeks 2, 6, and 10 (Study Weeks 14, 18, and 22)
- title
- Change From Baseline (BL) in Systolic Blood Pressure (SBP) and Diastolic BP (DBP)
- type
- SECONDARY
- unit Of Measure
- Millimeters of mercury (mmHg)
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Preserved source evidence · Not medical advice