Trial Outcomes & Findings for Investigation of Interactions Between Faldaprevir, Itraconazole, Atorvastatin and Rosuvastatin (NCT NCT01795937)
NCT ID: NCT01795937
Last Updated: 2015-08-03
Results Overview
Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval τ (AUCτ,ss) of faldaprevir. Outcome measure for the itraconazole part (treatment sequence A\_B) of this trial. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
51 participants
Primary outcome timeframe
-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h (hours) after administration of faldaprevir on Day 1 of both periods
Results posted on
2015-08-03
Participant Flow
Participant milestones
| Measure |
Treatment Sequence A_B (Itraconazole Part)
The itraconazole part (interaction of steady state faldaprevir with itraconazole) of this trial was done open-label with a fixed-sequence, 2-period design; performed independently from the statins part.
Treatment A: Faldaprevir (120 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 1 (6 days in total).
Treatment B: Faldaprevir (120 mg) was given once daily from Day -3 to Day 1 (4 days). In addition, itraconazole (200 mg) was given twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).
Treatment A directly preceded treatment B, without an intermittent washout period.
Oral administration with 240 mL water.
|
Treatment Sequence C_D (Statins Part)
The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.
Treatment C: Atorvastatin (10 mg) was given as a single dose on Day 1.
Treatment D: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.
Treatment C preceded treatment D.
Oral administration with 240 mL water.
|
Treatment Sequence E_F (Statins Part)
The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.
Treatment E: Rosuvastatin (10 mg) was given as a single dose on Day 1.
Treatment F: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.
Treatment E preceded treatment F.
Oral administration with 240 mL water.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
17
|
|
Overall Study
COMPLETED
|
17
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence A_B (Itraconazole Part)
The itraconazole part (interaction of steady state faldaprevir with itraconazole) of this trial was done open-label with a fixed-sequence, 2-period design; performed independently from the statins part.
Treatment A: Faldaprevir (120 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 1 (6 days in total).
Treatment B: Faldaprevir (120 mg) was given once daily from Day -3 to Day 1 (4 days). In addition, itraconazole (200 mg) was given twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).
Treatment A directly preceded treatment B, without an intermittent washout period.
Oral administration with 240 mL water.
|
Treatment Sequence C_D (Statins Part)
The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.
Treatment C: Atorvastatin (10 mg) was given as a single dose on Day 1.
Treatment D: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.
Treatment C preceded treatment D.
Oral administration with 240 mL water.
|
Treatment Sequence E_F (Statins Part)
The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.
Treatment E: Rosuvastatin (10 mg) was given as a single dose on Day 1.
Treatment F: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.
Treatment E preceded treatment F.
Oral administration with 240 mL water.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
Baseline Characteristics
Investigation of Interactions Between Faldaprevir, Itraconazole, Atorvastatin and Rosuvastatin
Baseline characteristics by cohort
| Measure |
Treatment Sequence A_B (Itraconazole Part)
n=18 Participants
The itraconazole part (interaction of steady state faldaprevir with itraconazole) of this trial was done open-label with a fixed-sequence, 2-period design; performed independently from the statins part.
Treatment A: Faldaprevir (120 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 1 (6 days in total).
Treatment B: Faldaprevir (120 mg) was given once daily from Day -3 to Day 1 (4 days). In addition, itraconazole (200 mg) was given twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).
Treatment A directly preceded treatment B, without an intermittent washout period.
Oral administration with 240 mL water.
|
Treatment Sequence C_D (Statins Part)
n=16 Participants
The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.
Treatment C: Atorvastatin (10 mg) was given as a single dose on Day 1.
Treatment D: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.
Treatment C preceded treatment D.
Oral administration with 240 mL water.
|
Treatment Sequence E_F (Statins Part)
n=17 Participants
The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.
Treatment E: Rosuvastatin (10 mg) was given as a single dose on Day 1.
Treatment F: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.
Treatment E preceded treatment F.
Oral administration with 240 mL water.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.8 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
40.0 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
38.1 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
39.3 years
STANDARD_DEVIATION 7.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h (hours) after administration of faldaprevir on Day 1 of both periodsPopulation: pharmacokinetic (PK) set of the itraconazole part of this trial. The PK set included all treated subjects of the itraconazole part that provided at least 1 observation for at least 1 primary endpoint without important protocal violations with respect to the statistical evaluation of the PK endpoints.
Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval τ (AUCτ,ss) of faldaprevir. Outcome measure for the itraconazole part (treatment sequence A\_B) of this trial. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Outcome measures
| Measure |
Faldaprevir
n=17 Participants
Faldaprevir 120 mg once daily from Day -4 to Day 1 with a 120 mg twice daily loading dose on Day -5 (6 days in total).
Treatment A.
|
Faldaprevir+Itraconazole
n=17 Participants
Faldaprevir 120 mg once daily from Day -3 to Day 1 + itraconazole 200 mg twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).
Treatment B.
|
|---|---|---|
|
AUCτ,ss (Itraconazole Part)
|
29900 ng*h/mL
Geometric Coefficient of Variation 62.8
|
59500 ng*h/mL
Geometric Coefficient of Variation 53.8
|
PRIMARY outcome
Timeframe: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h after administration of faldaprevir on Day 1 of both periods.Population: PK set of the itraconazole part of this trial.
Maximum measured concentration of the analyte in plasma at steady state over the dosing interval (Cmax,ss) of faldaprevir. Outcome measure for the itraconazole part (Treatment sequence A\_B) of this trial. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Outcome measures
| Measure |
Faldaprevir
n=17 Participants
Faldaprevir 120 mg once daily from Day -4 to Day 1 with a 120 mg twice daily loading dose on Day -5 (6 days in total).
Treatment A.
|
Faldaprevir+Itraconazole
n=17 Participants
Faldaprevir 120 mg once daily from Day -3 to Day 1 + itraconazole 200 mg twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).
Treatment B.
|
|---|---|---|
|
Cmax,ss (Itraconazole Part)
|
2780 ng/mL
Geometric Coefficient of Variation 61.0
|
5030 ng/mL
Geometric Coefficient of Variation 49.1
|
PRIMARY outcome
Timeframe: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods.Population: PK set of the statins part and assigned to atorvastatin (treatment sequence C\_D). Pharmacokinetic set (PK set): all treated subjects of the statins part that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of atorvastatin after single dose administration. Outcome measure for the statins part of this trial, treatment sequence C\_D. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Outcome measures
| Measure |
Faldaprevir
n=16 Participants
Faldaprevir 120 mg once daily from Day -4 to Day 1 with a 120 mg twice daily loading dose on Day -5 (6 days in total).
Treatment A.
|
Faldaprevir+Itraconazole
n=15 Participants
Faldaprevir 120 mg once daily from Day -3 to Day 1 + itraconazole 200 mg twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).
Treatment B.
|
|---|---|---|
|
AUC0-∞ of Atorvastatin (Statins Part)
|
13.7 ng*h/mL
Geometric Coefficient of Variation 51.5
|
129.0 ng*h/mL
Geometric Coefficient of Variation 43.7
|
PRIMARY outcome
Timeframe: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periodsPopulation: PK set of the statins part and assigned to atorvastatin (treatment sequence C\_D).
Maximum measured concentration of the analyte in plasma of atorvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence C\_D. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Outcome measures
| Measure |
Faldaprevir
n=16 Participants
Faldaprevir 120 mg once daily from Day -4 to Day 1 with a 120 mg twice daily loading dose on Day -5 (6 days in total).
Treatment A.
|
Faldaprevir+Itraconazole
n=15 Participants
Faldaprevir 120 mg once daily from Day -3 to Day 1 + itraconazole 200 mg twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).
Treatment B.
|
|---|---|---|
|
Cmax of Atorvastatin (Statins Part)
|
0.94 ng/mL
Geometric Coefficient of Variation 35.2
|
31.10 ng/mL
Geometric Coefficient of Variation 52.5
|
PRIMARY outcome
Timeframe: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periodsPopulation: PK set of the statins part and assigned to rosuvastatin (treatment sequence E\_F).
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of rosuvastatin after single dose administration of rosuvastatin. Outcome measure for the statins part of this trial, treatment sequence E\_F. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Outcome measures
| Measure |
Faldaprevir
n=17 Participants
Faldaprevir 120 mg once daily from Day -4 to Day 1 with a 120 mg twice daily loading dose on Day -5 (6 days in total).
Treatment A.
|
Faldaprevir+Itraconazole
n=17 Participants
Faldaprevir 120 mg once daily from Day -3 to Day 1 + itraconazole 200 mg twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).
Treatment B.
|
|---|---|---|
|
AUC0-∞ of Rosuvastatin (Statins Part)
|
24.9 ng*h/mL
Geometric Coefficient of Variation 49.3
|
365.0 ng*h/mL
Geometric Coefficient of Variation 28.6
|
PRIMARY outcome
Timeframe: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periodsPopulation: PK set of the statins part and assigned to rosuvastatin (treatment sequence E\_F).
Maximum measured concentration of the analyte in plasma of rosuvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence E\_F. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Outcome measures
| Measure |
Faldaprevir
n=17 Participants
Faldaprevir 120 mg once daily from Day -4 to Day 1 with a 120 mg twice daily loading dose on Day -5 (6 days in total).
Treatment A.
|
Faldaprevir+Itraconazole
n=17 Participants
Faldaprevir 120 mg once daily from Day -3 to Day 1 + itraconazole 200 mg twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).
Treatment B.
|
|---|---|---|
|
Cmax of Rosuvastatin
|
2.73 ng/mL
Geometric Coefficient of Variation 53.0
|
89.6 ng/mL
Geometric Coefficient of Variation 33.2
|
SECONDARY outcome
Timeframe: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence.Population: PK set of the statins part.
Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval τ (AUCτ,ss) of faldaprevir. Outcome measure for the statins part of this trial, treatment sequences C\_D and E\_F.
Outcome measures
| Measure |
Faldaprevir
n=15 Participants
Faldaprevir 120 mg once daily from Day -4 to Day 1 with a 120 mg twice daily loading dose on Day -5 (6 days in total).
Treatment A.
|
Faldaprevir+Itraconazole
n=17 Participants
Faldaprevir 120 mg once daily from Day -3 to Day 1 + itraconazole 200 mg twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).
Treatment B.
|
|---|---|---|
|
AUCτ,ss of Faldaprevir (Statins Part)
|
145000 ng*h/mL
Geometric Coefficient of Variation 34.3
|
136000 ng*h/mL
Geometric Coefficient of Variation 43.9
|
SECONDARY outcome
Timeframe: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence.Population: PK set of the statins part.
Maximum measured concentration of the analyte in plasma at steady state over the dosing interval (Cmax,ss) of faldaprevir. Outcome measure for the statins part of this trial, treatment sequences C\_D and E\_F.
Outcome measures
| Measure |
Faldaprevir
n=15 Participants
Faldaprevir 120 mg once daily from Day -4 to Day 1 with a 120 mg twice daily loading dose on Day -5 (6 days in total).
Treatment A.
|
Faldaprevir+Itraconazole
n=17 Participants
Faldaprevir 120 mg once daily from Day -3 to Day 1 + itraconazole 200 mg twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).
Treatment B.
|
|---|---|---|
|
Cmax,ss of Faldaprevir (Statins Part)
|
12900 ng/mL
Geometric Coefficient of Variation 27.8
|
12200 ng/mL
Geometric Coefficient of Variation 36.8
|
SECONDARY outcome
Timeframe: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periodsPopulation: PK set of the statins part and assigned to atorvastatin (treatment sequence C\_D).
Area under the plasma concentration-time curve of the analyte over the time interval from 0 to the time tz of the last measurable concentration (AUC0-tz) of atorvastatin. Outcome measure for the statins part of this trial, treatment sequence C\_D. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Outcome measures
| Measure |
Faldaprevir
n=16 Participants
Faldaprevir 120 mg once daily from Day -4 to Day 1 with a 120 mg twice daily loading dose on Day -5 (6 days in total).
Treatment A.
|
Faldaprevir+Itraconazole
n=15 Participants
Faldaprevir 120 mg once daily from Day -3 to Day 1 + itraconazole 200 mg twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).
Treatment B.
|
|---|---|---|
|
AUC0-tz of Atorvastatin
|
9.5 ng*h/mL
Geometric Coefficient of Variation 40.2
|
129.6 ng*h/mL
Geometric Coefficient of Variation 44.9
|
SECONDARY outcome
Timeframe: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periodsPopulation: PK set of the statins part and assigned to rosuvastatin (treatment sequence E\_F).
Area under the plasma concentration-time curve of the analyte over the time interval from 0 to the time tz of the last measurable concentration (AUC0-tz) of rosuvastatin. Outcome measure for the statins part of this trial, treatment sequence E\_F. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Outcome measures
| Measure |
Faldaprevir
n=17 Participants
Faldaprevir 120 mg once daily from Day -4 to Day 1 with a 120 mg twice daily loading dose on Day -5 (6 days in total).
Treatment A.
|
Faldaprevir+Itraconazole
n=17 Participants
Faldaprevir 120 mg once daily from Day -3 to Day 1 + itraconazole 200 mg twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).
Treatment B.
|
|---|---|---|
|
AUC0-tz of Rosuvastatin
|
21.5 ng*h/mL
Geometric Coefficient of Variation 48.0
|
361.0 ng*h/mL
Geometric Coefficient of Variation 28.8
|
Adverse Events
Faldaprevir (Itraconazole Part)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Faldaprevir+Itraconazole (Itraconazole Part)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Atorvastatin (Statins Part)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Rosuvastatin (Statins Part)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Faldaprevir (Statins Part)
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Faldaprevir + Atorvastatin (Statins Part)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Faldaprevir + Rosuvastatin (Statins Part)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Faldaprevir (Itraconazole Part)
n=18 participants at risk
Faldaprevir: 120 mg once daily with a 120 mg twice daily loading dose on Day -5.
Treatment A.
|
Faldaprevir+Itraconazole (Itraconazole Part)
n=17 participants at risk
Faldaprevir: 120 mg once daily. Itraconazole: 200 mg once daily with a 200 mg twice daily loading dose on Day -3.
Treatment B.
|
Atorvastatin (Statins Part)
n=16 participants at risk
Atorvastatin: 10 mg was given as a single dose on Day 1.
Treatment C.
From the time of the single dose atorvastatin administration in treatment C until the time of the first faldaprevir administration in treatment D or until 1 day after the trial completion date of the respective subject.
|
Rosuvastatin (Statins Part)
n=17 participants at risk
Rosuvastatin: 10 mg was given as a single dose on Day 1.
Treatment E.
From the time of the single dose rosuvastatin administration in treatment E until the time of the first faldaprevir administration in treatment F or until 1 day after the trial completion date.
|
Faldaprevir (Statins Part)
n=32 participants at risk
From the time of the first faldaprevir administration in treatment D or F until the combined administration of faldaprevir with atorvastatin or rosuvastatin in treatment D or F, respectively, or until 1 day after the trial completion date.
|
Faldaprevir + Atorvastatin (Statins Part)
n=15 participants at risk
Faldaprevir: 240 mg was given twice daily on Day -5 and once daily from Day -4 to Day 2. Atorvastatin: 10 mg was given as a single dose on Day 1.
Treatment D.
From the time of the combined administration of faldaprevir with atorvastatin in treatment D until 1 day after the trial completion date.
|
Faldaprevir + Rosuvastatin (Statins Part)
n=17 participants at risk
Faldaprevir: 240 mg was given twice daily on Day -5 and once daily from Day -4 to Day 2. Rosuvastatin: 10 mg was given as a single dose on Day 1.
Treatment F.
From the time of the combined administration of faldaprevir with rosuvastatin in treatment F until 1 day after the trial completion date.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
11.1%
2/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
6.2%
1/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
5.9%
1/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
3.1%
1/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
6.2%
1/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
5.9%
1/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
6.2%
1/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Nervous system disorders
Headache
|
55.6%
10/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
11.8%
2/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
9.4%
3/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
13.3%
2/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
17.6%
3/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
6.2%
2/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
6.7%
1/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Eye disorders
Ocular icterus
|
5.6%
1/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
12.5%
4/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
33.3%
5/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
17.6%
3/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
5.9%
1/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Vascular disorders
Haematoma
|
0.00%
0/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
5.9%
1/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
6.7%
1/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
6.2%
1/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
5.9%
1/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
2/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
5.9%
1/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
40.6%
13/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
11.8%
2/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
5.9%
1/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
5.9%
1/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
1/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
18.8%
6/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
9.4%
3/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
6.2%
1/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
6.2%
2/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
6.7%
1/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
6.7%
1/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
5.9%
1/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
13.3%
2/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
6.2%
1/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
6.7%
1/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
6.7%
1/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
General disorders
Fatigue
|
33.3%
6/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
5.9%
1/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
15.6%
5/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
General disorders
Thirst
|
0.00%
0/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
5.9%
1/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
13.3%
2/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/18 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/16 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/32 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
0.00%
0/15 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
5.9%
1/17 • Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place