Trial Outcomes & Findings for A Study to Compare Brachial Artery Reactivity and Cardiovascular Risk of a Treatment Simplification by Darunavir/Ritonavir (DRV/r) 800/100 mg Versus a Triple Combination Therapy Containing DRV/r in HIV-1 Infected Patients (NCT NCT01391013)
NCT ID: NCT01391013
Last Updated: 2013-06-27
Results Overview
Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia (an increase in the quantity of blood flow to a body part) induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter.
COMPLETED
PHASE2
30 participants
Baseline (Day 1 of Week 1) to Week 24
2013-06-27
Participant Flow
30 participants were enrolled at a single site in Italy.
30 participants were randomly assigned to 2 treatment groups (15 participants in each group) and all participants received the study medication.
Participant milestones
| Measure |
Monotherapy
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
|
Combination Therapy
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Compare Brachial Artery Reactivity and Cardiovascular Risk of a Treatment Simplification by Darunavir/Ritonavir (DRV/r) 800/100 mg Versus a Triple Combination Therapy Containing DRV/r in HIV-1 Infected Patients
Baseline characteristics by cohort
| Measure |
Monotherapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
|
Combination Therapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
44.8 Years
n=5 Participants
|
43.0 Years
n=7 Participants
|
44.6 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1 of Week 1) to Week 24Population: Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.
Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia (an increase in the quantity of blood flow to a body part) induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter.
Outcome measures
| Measure |
Combination Therapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
|
Monotherapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
|
|---|---|---|
|
Change From Baseline to Week 24 in Brachial Artery Flow Mediated Vasodilatation (FMD): Median Change in FMD (%)
|
-0.6 Percentage of brachial artery diameter
Interval -4.7 to 3.3
|
-4.8 Percentage of brachial artery diameter
Interval -7.0 to 0.3
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.
Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter.
Outcome measures
| Measure |
Combination Therapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
|
Monotherapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
|
|---|---|---|
|
Change From Baseline to Week 48 in Brachial Artery FMD: Median Change in FMD (%)
|
-3 Percentage of brachial artery diameter
Interval -4.5 to 4.0
|
-4.4 Percentage of brachial artery diameter
Interval -6.2 to 2.6
|
SECONDARY outcome
Timeframe: Screening (Week -4), Week 1 (Day 1), Week 4, Week 12, Week 24, Week 36, Week 48, and follow-up (Week 52)Population: Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.
Outcome measures
| Measure |
Combination Therapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
|
Monotherapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
|
|---|---|---|
|
Number of Participants With a Human Immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) Greater Than or Equal to 50 Copies/mL
Week 48
|
0 Participants
|
1 Participants
|
|
Number of Participants With a Human Immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) Greater Than or Equal to 50 Copies/mL
Screening (Week -4)
|
0 Participants
Interval -4.5 to 4.0
|
0 Participants
Interval -6.2 to 2.6
|
|
Number of Participants With a Human Immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) Greater Than or Equal to 50 Copies/mL
Week 1 (Day 1)
|
0 Participants
|
1 Participants
|
|
Number of Participants With a Human Immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) Greater Than or Equal to 50 Copies/mL
Week 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Human Immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) Greater Than or Equal to 50 Copies/mL
Week 12
|
1 Participants
|
0 Participants
|
|
Number of Participants With a Human Immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) Greater Than or Equal to 50 Copies/mL
Week 24
|
1 Participants
|
0 Participants
|
|
Number of Participants With a Human Immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) Greater Than or Equal to 50 Copies/mL
Week 36
|
0 Participants
|
2 Participants
|
|
Number of Participants With a Human Immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) Greater Than or Equal to 50 Copies/mL
Follow up (Week 52)
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.
Outcome measures
| Measure |
Combination Therapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
|
Monotherapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
|
|---|---|---|
|
Change From Baseline to Week 48 in Circulating Endothelial Cells
Baseline
|
14.6 Endothelial cells
Interval 0.0 to 551.4
|
5.09 Endothelial cells
Interval 0.0 to 105.6
|
|
Change From Baseline to Week 48 in Circulating Endothelial Cells
Week 48
|
64 Endothelial cells
Interval 0.0 to 4256.0
|
37 Endothelial cells
Interval 0.0 to 5533.0
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.
Outcome measures
| Measure |
Combination Therapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
|
Monotherapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
|
|---|---|---|
|
Change From Baseline to Week 48 in Precursors of Circulating Endothelial Cells
Baseline
|
18 Endothelial cells
Interval 0.0 to 93.0
|
16 Endothelial cells
Interval 0.0 to 60.0
|
|
Change From Baseline to Week 48 in Precursors of Circulating Endothelial Cells
Week 48
|
108 Endothelial cells
Interval 0.0 to 715.0
|
120 Endothelial cells
Interval 0.0 to 519.0
|
SECONDARY outcome
Timeframe: Baseline (Day1 of Week 1), Week 24, and Week 48Population: Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.
Outcome measures
| Measure |
Combination Therapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
|
Monotherapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
|
|---|---|---|
|
Change From Baseline in Mean Low-density Lipoprotein (LDL) Cholesterol at Week 24 and Week 48: Median Change in LDL
Week 24
|
6 mg/dL
Interval -17.0 to 20.0
|
17 mg/dL
Interval 0.0 to 40.0
|
|
Change From Baseline in Mean Low-density Lipoprotein (LDL) Cholesterol at Week 24 and Week 48: Median Change in LDL
Week 48
|
5 mg/dL
Interval -12.0 to 19.0
|
14 mg/dL
Interval 7.0 to 42.0
|
SECONDARY outcome
Timeframe: Baseline, Week 24, and Week 48Population: Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.
Outcome measures
| Measure |
Combination Therapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
|
Monotherapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
|
|---|---|---|
|
Change From Baseline in Mean High-density Lipoprotein (HDL) Cholesterol at Week 24 and Week 48: Median Change in HDL
Week 24
|
-6 mg/dL
Interval -9.0 to 4.0
|
-1 mg/dL
Interval -6.0 to 3.0
|
|
Change From Baseline in Mean High-density Lipoprotein (HDL) Cholesterol at Week 24 and Week 48: Median Change in HDL
Week 48
|
-6 mg/dL
Interval -11.0 to -1.0
|
-4 mg/dL
Interval -5.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, Week 24, and Week 48Population: Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.
Outcome measures
| Measure |
Combination Therapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
|
Monotherapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
|
|---|---|---|
|
Change From Baseline in Mean Triglycerides at Week 24 and Week 48: Median Change in Triglycerides
Week 24
|
-1 mg/dL
Interval -28.0 to 25.0
|
15 mg/dL
Interval -18.0 to 42.0
|
|
Change From Baseline in Mean Triglycerides at Week 24 and Week 48: Median Change in Triglycerides
Week 48
|
6 mg/dL
Interval -8.0 to 38.0
|
24 mg/dL
Interval -15.0 to 64.0
|
SECONDARY outcome
Timeframe: Baseline, Week 24, and Week 48Population: Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.
The Homeostatic Model Assessment (HOMA) is a method used to quantify insulin resistance and beta-cell function. HOMA-IR is reflected in the diminished effect of insulin on hepatic glucose production. HOMA-IR is calculated as: (Glucose \[mg/dL\] X Insulin \[pmol/L\]) / (405 X 6.945). Higher scores indicate worse insulin resistance.
Outcome measures
| Measure |
Combination Therapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
|
Monotherapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
|
|---|---|---|
|
Change From Baseline in Insulin Sensitivity at Week 24 and Week 48: Median Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Week 24
|
-0.3 HOMA score
Interval -1.1 to 0.3
|
-0.2 HOMA score
Interval -1.4 to 0.6
|
|
Change From Baseline in Insulin Sensitivity at Week 24 and Week 48: Median Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Week 48
|
-0.5 HOMA score
Interval -1.6 to -0.1
|
-0.6 HOMA score
Interval -1.1 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, Week 24, and Week 48Population: Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.
The Framingham Risk Score is used to estimate the 10-year cardiovascular risk of a participant. It is calculated according to age, laboratory values of total cholesterol and HDL cholesterol, smoking status, and systolic blood pressure. The framingham risk score is calculated as: for males: 0 point (1 percentage) up to 17 points (30 percentages); whereas for females: 0 to 9 points (1 percentage) up to 25 points (30 percentage). Higher scores indicate high cardiovascular risk.
Outcome measures
| Measure |
Combination Therapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
|
Monotherapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
|
|---|---|---|
|
Change From Baseline in Mean Framingham Risk Score at Week 24 and Week 48: Medican Change in Framingham Risk Score
Week 24
|
0 Framingham risk score
Interval -1.0 to 3.0
|
0 Framingham risk score
Interval 0.0 to 1.0
|
|
Change From Baseline in Mean Framingham Risk Score at Week 24 and Week 48: Medican Change in Framingham Risk Score
Week 48
|
1 Framingham risk score
Interval 0.0 to 3.0
|
1 Framingham risk score
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.
Leg fat content will be analyzed by Dual Energy X-ray Absortiometry (DEXA scan).
Outcome measures
| Measure |
Combination Therapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
|
Monotherapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
|
|---|---|---|
|
Change From Baseline to Week 48 in Leg Fat Content: Median Change in Leg Fat (Total)
|
-288 Percentage of fat
Interval -794.0 to 601.0
|
-57 Percentage of fat
Interval -447.0 to 419.0
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.
Visceral fat content in abdomen will be analyzed with median change in VAT by an abdomen Computerized Tomography.
Outcome measures
| Measure |
Combination Therapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
|
Monotherapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
|
|---|---|---|
|
Change From Baseline to Week 48 in Visceral Fat Content in Abdomen: Median Change in Visceral Abdominal Tissue (VAT)
|
-4 cm square
Interval -15.0 to 19.0
|
-4 cm square
Interval -38.0 to 4.0
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.
T score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. T score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as a participant. This score is calculated from participant's age, gender and race and skeletal site. T score has a mean of '50' and a standard deviation of '10'. T score lower than its mean indicate low bone mineral density.
Outcome measures
| Measure |
Combination Therapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
|
Monotherapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
|
|---|---|---|
|
Change From Baseline to Week 48 in Femoral Neck T Score: Median Change in Femoral Neck T Score
|
-0.1 T score
Interval -0.2 to 0.2
|
0.2 T score
Interval -0.1 to 0.4
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.
Z score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. Z score is the number of standard deviations above or below the mean for the participant's age, sex and ethnicity. This score is calculated from participant's age, gender and race and skeletal site. Z score has a mean of '0' and a standard deviation of '1'. Z score lower than its mean indicate low bone mineral density.
Outcome measures
| Measure |
Combination Therapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
|
Monotherapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
|
|---|---|---|
|
Change From Baseline to Week 48 in Femoral Neck Z Score: Median Change in Femoral Neck Z Score
|
0.0 Z score
Interval -0.1 to 0.2
|
0.2 Z score
Interval -0.1 to 0.4
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.
T score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. T score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as a participant. This score is calculated from participant's age, gender and race and skeletal site. T score has a mean of '50' and a standard deviation of '10'. T score lower than its mean indicate low bone mineral density.
Outcome measures
| Measure |
Combination Therapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
|
Monotherapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
|
|---|---|---|
|
Change From Baseline to Week 48 in Lumbar T Score: Median Change in Lumbar T Score
|
0.0 T score
Interval -0.2 to 0.1
|
0.1 T score
Interval 0.0 to 0.3
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.
Z score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. Z score is the number of standard deviations above or below the mean for the participant's age, sex and ethnicity. This score is calculated from participant's age, gender and race and skeletal site. Z score has a mean of '0' and a standard deviation of '1'. Z score lower than its mean indicate low bone mineral density.
Outcome measures
| Measure |
Combination Therapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
|
Monotherapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
|
|---|---|---|
|
Change From Baseline to Week 48 in Lumbar Z Score: Median Change in Lumbar Z Score
|
0.0 Z score
Interval -0.2 to 0.1
|
0.1 Z score
Interval 0.0 to 0.3
|
SECONDARY outcome
Timeframe: Screening (Week -4), Week 1 (Day 1), Week 4, Week 12, Week 24, Week 36, Week 48, and follow-up (Week 52)Population: Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.
Outcome measures
| Measure |
Combination Therapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
|
Monotherapy
n=15 Participants
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
|
|---|---|---|
|
Change From Baseline in Cluster of Differentiation 4 (CD4) Count Over Week 48
Week 24
|
-12 CD4 cells
Interval -67.0 to 70.0
|
6 CD4 cells
Interval -48.0 to 58.0
|
|
Change From Baseline in Cluster of Differentiation 4 (CD4) Count Over Week 48
Week 48
|
60 CD4 cells
Interval -69.0 to 122.0
|
100.1 CD4 cells
Interval 32.0 to 135.0
|
Adverse Events
Monotherapy
Combination Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Monotherapy
n=15 participants at risk
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
|
Combination Therapy
n=15 participants at risk
2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • 52 weeks
|
20.0%
3/15 • 52 weeks
|
|
General disorders
Malaise
|
6.7%
1/15 • 52 weeks
|
6.7%
1/15 • 52 weeks
|
|
General disorders
Pyrexia
|
20.0%
3/15 • 52 weeks
|
6.7%
1/15 • 52 weeks
|
|
Infections and infestations
Influenza
|
13.3%
2/15 • 52 weeks
|
6.7%
1/15 • 52 weeks
|
|
Investigations
Blood cholesterol increased
|
26.7%
4/15 • 52 weeks
|
0.00%
0/15 • 52 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/15 • 52 weeks
|
13.3%
2/15 • 52 weeks
|
|
Investigations
Blood triglycerides increased
|
6.7%
1/15 • 52 weeks
|
6.7%
1/15 • 52 weeks
|
|
Investigations
Low density lipoprotein increased
|
26.7%
4/15 • 52 weeks
|
0.00%
0/15 • 52 weeks
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • 52 weeks
|
6.7%
1/15 • 52 weeks
|
|
Psychiatric disorders
Insomnia
|
13.3%
2/15 • 52 weeks
|
0.00%
0/15 • 52 weeks
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • 52 weeks
|
6.7%
1/15 • 52 weeks
|
Additional Information
Therapeutic Area Medical Manager
Jan-Cil Italy
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60