Trial Outcomes & Findings for Efficacy of Minoxidil in Children With Williams-Beuren Syndrome (NCT NCT00876200)
NCT ID: NCT00876200
Last Updated: 2025-09-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
12 months
Results posted on
2025-09-30
Participant Flow
Participant milestones
| Measure |
Minoxidil
Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.
Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more.
Minoxidil: Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.
Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more.
|
Placebo
Placebo = lactose
Placebo: Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.
Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
12
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Minoxidil
n=9 Participants
Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.
Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more.
Minoxidil: Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.
Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more.
|
Placebo
n=12 Participants
Placebo = lactose
Placebo: Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.
Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.33 years
STANDARD_DEVIATION 4.42 • n=9 Participants
|
10.75 years
STANDARD_DEVIATION 3.77 • n=12 Participants
|
11.43 years
STANDARD_DEVIATION 4.03 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=9 Participants
|
4 Participants
n=12 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=9 Participants
|
8 Participants
n=12 Participants
|
12 Participants
n=21 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
History of hypertension
|
2 Participants
n=9 Participants
|
2 Participants
n=12 Participants
|
4 Participants
n=21 Participants
|
|
History of cardiovascular disease
|
4 Participants
n=9 Participants
|
6 Participants
n=12 Participants
|
10 Participants
n=21 Participants
|
|
Systolic Blood Pressure
|
128.11 mmHg
STANDARD_DEVIATION 16.78 • n=9 Participants
|
120.83 mmHg
STANDARD_DEVIATION 12.68 • n=12 Participants
|
123.95 mmHg
STANDARD_DEVIATION 14.65 • n=21 Participants
|
|
Diastolic Blood Pressure
|
78.22 mmHg
STANDARD_DEVIATION 15.58 • n=9 Participants
|
73.17 mmHg
STANDARD_DEVIATION 8.97 • n=12 Participants
|
75.33 mmHg
STANDARD_DEVIATION 12.16 • n=21 Participants
|
|
BMI
|
17.93 Kg/cm2
STANDARD_DEVIATION 3.88 • n=9 Participants
|
17.54 Kg/cm2
STANDARD_DEVIATION 3.30 • n=12 Participants
|
17.71 Kg/cm2
STANDARD_DEVIATION 3.47 • n=21 Participants
|
PRIMARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Minoxidil
n=9 Participants
Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.
Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more.
Minoxidil: Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.
Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more.
|
Placebo
n=9 Participants
Placebo = lactose
Placebo: Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.
Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more.
|
|---|---|---|
|
Variation of Carotid Intima-media Thickness (IMT) Assessed by Vascular Echography
|
0.028 mm
Interval 0.002 to 0.058
|
0.012 mm
Interval 0.0017 to 0.04
|
SECONDARY outcome
Timeframe: 18 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0Outcome measures
Outcome data not reported
Adverse Events
Minoxidil
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Minoxidil
n=9 participants at risk
Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.
Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more.
Minoxidil: Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.
Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more.
|
Placebo
n=12 participants at risk
Placebo = lactose
Placebo: Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.
Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Flat foot
|
0.00%
0/9
|
8.3%
1/12 • Number of events 1
|
|
Surgical and medical procedures
Strabismus correction
|
11.1%
1/9 • Number of events 1
|
0.00%
0/12
|
Other adverse events
| Measure |
Minoxidil
n=9 participants at risk
Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.
Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more.
Minoxidil: Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.
Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more.
|
Placebo
n=12 participants at risk
Placebo = lactose
Placebo: Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.
Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
55.6%
5/9 • Number of events 5
|
0.00%
0/12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place