Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Tolerability of Topical Therapies for the Condition of Plaque-Type Psoriasis (NCT NCT00852761)

NCT ID: NCT00852761

Last Updated: 2012-04-23

Results Overview

Number of participants who achieved a minimum 1-grade improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 34 participants
• Primary outcome timeframe: Baseline to day 15
• Results posted on: 2012-04-23

Participant Flow

Clinical research center

Participant milestones

Measure	Olux-E Foam Olux-E (Clobetasol propionate 0.05 percent) foam. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.	Clobex Lotion Clobex (Clobetasol propionate 0.05 percent) lotion. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
Overall Study STARTED	17	17
Overall Study COMPLETED	17	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Efficacy and Tolerability of Topical Therapies for the Condition of Plaque-Type Psoriasis

Baseline characteristics by cohort

Measure	Olux-E Foam n=17 Participants Olux-E (Clobetasol propionate 0.05 percent) foam. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.	Clobex Lotion n=17 Participants Clobex (Clobetasol propionate 0.05 percent) lotion. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.	Total n=34 Participants Total of all reporting groups
Age, Customized	48.2 years STANDARD_DEVIATION 11.7 • n=5 Participants	48.6 years STANDARD_DEVIATION 13 • n=7 Participants	48.4 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	17 participants n=7 Participants	34 participants n=5 Participants
Body Mass Index	31.2 kg/m^2 STANDARD_DEVIATION 6.4 • n=5 Participants	30.0 kg/m^2 STANDARD_DEVIATION 8.8 • n=7 Participants	30.6 kg/m^2 STANDARD_DEVIATION 7.6 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to day 15

Population: ITT

Number of participants who achieved a minimum 1-grade improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.

Outcome measures

Measure	Olux-E Foam n=17 Participants Olux-E (clobetasol propionate 0.05%) foam	Clobex Lotion n=17 Participants Clobex (clobetasol propionate 0.05%) lotion.
At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale)	15 participants	14 participants

SECONDARY outcome

Timeframe: Baseline, days 3 and 8

Population: Intent to treat (ITT)

Number of participants who achieve a minimum one grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.

The scale is the same as used for the primary outcome (0 through 5).

Outcome measures

Measure	Olux-E Foam n=17 Participants Olux-E (clobetasol propionate 0.05%) foam	Clobex Lotion n=17 Participants Clobex (clobetasol propionate 0.05%) lotion.
At Least 1 Grade Improvement Psoriasis Grading Scale Day 3	9 participants	10 participants
At Least 1 Grade Improvement Psoriasis Grading Scale Day 8	14 participants	14 participants

SECONDARY outcome

Timeframe: Baseline, days 3, 8, 15

Population: Intent to treat (ITT)

Number of participants who achieve a minimum two grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.

The scale is the same as used for the primary outcome (0 through 5).

Outcome measures

Measure	Olux-E Foam n=17 Participants Olux-E (clobetasol propionate 0.05%) foam	Clobex Lotion n=17 Participants Clobex (clobetasol propionate 0.05%) lotion.
At Least a 2 Grade Improvement Psoriasis Grading Scale Day 3	2 participants	1 participants
At Least a 2 Grade Improvement Psoriasis Grading Scale Day 8	5 participants	13 participants
At Least a 2 Grade Improvement Psoriasis Grading Scale Day 15	5 participants	13 participants

SECONDARY outcome

Timeframe: Baseline, days 3, 8, 15

Population: Intent to treat (ITT)

Number of participants who achieve a minimum of three grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.

The scale is the same as used for the primary outcome (0 through 5).

Outcome measures

Measure	Olux-E Foam n=17 Participants Olux-E (clobetasol propionate 0.05%) foam	Clobex Lotion n=17 Participants Clobex (clobetasol propionate 0.05%) lotion.
At Least a 3 Grade Improvement Psoriasis Grading Scale Day 8	0 participants	2 participants
At Least a 3 Grade Improvement Psoriasis Grading Scale Day 15	0 participants	4 participants

SECONDARY outcome

Timeframe: Baseline, days 3, 8, 15

Population: Intent to treat (ITT)

Number of participants who acheive at least a 1 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.

Outcome measures

Measure	Olux-E Foam n=17 Participants Olux-E (clobetasol propionate 0.05%) foam	Clobex Lotion n=17 Participants Clobex (clobetasol propionate 0.05%) lotion.
At Least 1 Grade Improvement in the Psoriasis Global Assessment Day 3	6 participants	7 participants
At Least 1 Grade Improvement in the Psoriasis Global Assessment Day 8	10 participants	13 participants
At Least 1 Grade Improvement in the Psoriasis Global Assessment Day 15	14 participants	14 participants

SECONDARY outcome

Timeframe: Baseline, days 3, 8, 15

Population: Intent to treat (ITT)

Number of participants who acheive at least a 2 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.

Outcome measures

Measure	Olux-E Foam n=17 Participants Olux-E (clobetasol propionate 0.05%) foam	Clobex Lotion n=17 Participants Clobex (clobetasol propionate 0.05%) lotion.
At Least a 2 Grade Improvement in the Psoriasis Global Assessment Day 3	0 participants	1 participants
At Least a 2 Grade Improvement in the Psoriasis Global Assessment Day 8	6 participants	7 participants
At Least a 2 Grade Improvement in the Psoriasis Global Assessment Day 15	3 participants	10 participants

SECONDARY outcome

Timeframe: Baseline, days 3, 8, 15

Population: Intent to treat (ITT)

Number of participants who acheive at least a 3 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.

Outcome measures

Measure	Olux-E Foam n=17 Participants Olux-E (clobetasol propionate 0.05%) foam	Clobex Lotion n=17 Participants Clobex (clobetasol propionate 0.05%) lotion.
At Least a 3 Grade Improvement in the Psoriasis Global Assessment Day 3	0 participants	0 participants
At Least a 3 Grade Improvement in the Psoriasis Global Assessment Day 8	0 participants	0 participants
At Least a 3 Grade Improvement in the Psoriasis Global Assessment Day 15	0 participants	3 participants

SECONDARY outcome

Timeframe: Baseline, days 3, 8, 15

Population: Intent to treat (ITT)

Number of participants who achieve treatment success (minimum one grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.

Outcome measures

Measure	Olux-E Foam n=17 Participants Olux-E (clobetasol propionate 0.05%) foam	Clobex Lotion n=17 Participants Clobex (clobetasol propionate 0.05%) lotion.
At Least 1 Grade Improvement in Subject's Global Assessment Day 3	8 participants	12 participants
At Least 1 Grade Improvement in Subject's Global Assessment Day 8	15 participants	16 participants
At Least 1 Grade Improvement in Subject's Global Assessment Day 15	15 participants	17 participants

SECONDARY outcome

Timeframe: Baseline, days 3, 8, 15

Population: Intent to treat (ITT)

Number of participants who achieve treatment success (minimum two grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.

Outcome measures

Measure	Olux-E Foam n=17 Participants Olux-E (clobetasol propionate 0.05%) foam	Clobex Lotion n=17 Participants Clobex (clobetasol propionate 0.05%) lotion.
At Least a 2 Grade Improvement in Subject's Global Assessment Day 3	4 participants	3 participants
At Least a 2 Grade Improvement in Subject's Global Assessment Day 8	10 participants	11 participants
At Least a 2 Grade Improvement in Subject's Global Assessment Day 15	13 participants	14 participants

SECONDARY outcome

Timeframe: Baseline, days 3, 8, 15

Population: Intent to treat (ITT)

Number of participants who achieve treatment success (minimum three grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.

Outcome measures

Measure	Olux-E Foam n=17 Participants Olux-E (clobetasol propionate 0.05%) foam	Clobex Lotion n=17 Participants Clobex (clobetasol propionate 0.05%) lotion.
At Least a 3 Grade Improvement in Subject's Global Assessment Day 3	0 participants	0 participants
At Least a 3 Grade Improvement in Subject's Global Assessment Day 8	6 participants	8 participants
At Least a 3 Grade Improvement in Subject's Global Assessment Day 15	8 participants	11 participants

SECONDARY outcome

Timeframe: Baseline, Days 3, 8, 15

Population: ITT

Median improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.

Outcome measures

Measure	Olux-E Foam n=17 Participants Olux-E (clobetasol propionate 0.05%) foam	Clobex Lotion n=17 Participants Clobex (clobetasol propionate 0.05%) lotion.
Median Change in Psoriasis Grading Scale Day 3	-1 unites on a scale Interval -1.0 to 0.0	-1 unites on a scale Interval -1.0 to 0.0
Median Change in Psoriasis Grading Scale Day 8	-1 unites on a scale Interval -2.0 to -1.0	-2 unites on a scale Interval -2.0 to -1.0
Median Change in Psoriasis Grading Scale Day 15	-1 unites on a scale Interval -2.0 to -1.0	-2 unites on a scale Interval -2.0 to -2.0

SECONDARY outcome

Timeframe: Baseline, Days 3, 8, 15

Population: ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)

Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.

Sum of scores for questions 1 and 2. Score range from 0 to 6. A higher score denotes a more impaired quality of life

Outcome measures

Measure	Olux-E Foam n=17 Participants Olux-E (clobetasol propionate 0.05%) foam	Clobex Lotion n=17 Participants Clobex (clobetasol propionate 0.05%) lotion.
Dermatology Quality of Life - Symptoms and Feelings Day 3, n=16, 17	1.94 units on a scale Standard Deviation 1.12	2.41 units on a scale Standard Deviation 1.70
Dermatology Quality of Life - Symptoms and Feelings Day 8, n=17, 17	1.06 units on a scale Standard Deviation 1.2	1.35 units on a scale Standard Deviation 1.32
Dermatology Quality of Life - Symptoms and Feelings Day 15, n=17, 17	0.82 units on a scale Standard Deviation 0.95	0.94 units on a scale Standard Deviation 1.14

SECONDARY outcome

Timeframe: Baseline, Days 3, 8, 15

Population: ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)

Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.

Sum of scores for questions 3 and 4. Score range from 0 to 6. A higher score denotes a more impaired quality of life

Outcome measures

Measure	Olux-E Foam n=17 Participants Olux-E (clobetasol propionate 0.05%) foam	Clobex Lotion n=17 Participants Clobex (clobetasol propionate 0.05%) lotion.
Dermatology Quality of Life - Daily Activities Day 3, n=16, 17	0.56 units on a scale Standard Deviation 0.96	1.41 units on a scale Standard Deviation 1.23
Dermatology Quality of Life - Daily Activities Day 8, n=17, 17	0.53 units on a scale Standard Deviation 0.94	0.88 units on a scale Standard Deviation 1.05
Dermatology Quality of Life - Daily Activities Day 15, n=17, 17	0.53 units on a scale Standard Deviation 1.07	0.82 units on a scale Standard Deviation 1.29

SECONDARY outcome

Timeframe: Baseline, Days 3, 8, 15

Population: ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)

Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.

Sum of scores for questions 5 and 6. Score range from 0 to 6. A higher score denotes a more impaired quality of life

Outcome measures

Measure	Olux-E Foam n=17 Participants Olux-E (clobetasol propionate 0.05%) foam	Clobex Lotion n=17 Participants Clobex (clobetasol propionate 0.05%) lotion.
Dermatology Quality of Life - Leisure Day 3, n=16, 17	0.5 units on a scale Standard Deviation 0.97	0.94 units on a scale Standard Deviation 1.30
Dermatology Quality of Life - Leisure Day 8, n=17, 17	0.47 units on a scale Standard Deviation 0.94	0.41 units on a scale Standard Deviation 0.87
Dermatology Quality of Life - Leisure Day 15, n=17, 17	0.35 units on a scale Standard Deviation 1.0	0.24 units on a scale Standard Deviation 0.56

SECONDARY outcome

Timeframe: Baseline, Days 3, 8, 15

Population: ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)

Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.

Sum of scores for questions 7. Score range from 0 to 3. A higher score denotes a more impaired quality of life

Outcome measures

Measure	Olux-E Foam n=17 Participants Olux-E (clobetasol propionate 0.05%) foam	Clobex Lotion n=17 Participants Clobex (clobetasol propionate 0.05%) lotion.
Dermatology Quality of Life - Work and School Day 3, n=15, 17	0.13 units on a scale Standard Deviation 0.35	0.24 units on a scale Standard Deviation 0.56
Dermatology Quality of Life - Work and School Day 8, n=16, 17	0.06 units on a scale Standard Deviation 0.25	0.12 units on a scale Standard Deviation 0.33
Dermatology Quality of Life - Work and School Day 15, n=17, 17	0.06 units on a scale Standard Deviation 0.24	0.06 units on a scale Standard Deviation 0.24

SECONDARY outcome

Timeframe: Baseline, Days 3, 8, 15

Population: ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)

Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.

Sum of scores for questions 8 and 9. Score range from 0 to 6. A higher score denotes a more impaired quality of life

Outcome measures

Measure	Olux-E Foam n=17 Participants Olux-E (clobetasol propionate 0.05%) foam	Clobex Lotion n=17 Participants Clobex (clobetasol propionate 0.05%) lotion.
Dermatology Quality of Life - Personal Relationships Day 3, n=15, 17	0.33 units on a scale Standard Deviation 0.49	0.41 units on a scale Standard Deviation 0.80
Dermatology Quality of Life - Personal Relationships Day 8, n=16, 17	0.25 units on a scale Standard Deviation 0.45	0.29 units on a scale Standard Deviation 0.77
Dermatology Quality of Life - Personal Relationships Day 15, n=17, 17	0.18 units on a scale Standard Deviation 0.53	0.12 units on a scale Standard Deviation 0.33

SECONDARY outcome

Timeframe: Baseline, Days 3, 8, 15

Population: ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)

Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.

Sum of scores for question 10. Score range from 0 to 3. A higher score denotes a more impaired quality of life

Outcome measures

Measure	Olux-E Foam n=17 Participants Olux-E (clobetasol propionate 0.05%) foam	Clobex Lotion n=17 Participants Clobex (clobetasol propionate 0.05%) lotion.
Dermatology Quality of Life - Treatment Day 3, n=16, 17	0.31 units on a scale Standard Deviation 0.60	0.35 units on a scale Standard Deviation 0.61
Dermatology Quality of Life - Treatment Day 8, n=17, 17	0.29 units on a scale Standard Deviation 0.59	0.24 units on a scale Standard Deviation 0.44
Dermatology Quality of Life - Treatment Day 15, n=17, 17	0.18 units on a scale Standard Deviation 0.39	0.24 units on a scale Standard Deviation 0.44

SECONDARY outcome

Timeframe: Baseline, Days 3, 8, 15

Population: ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)

Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.

Sum of scores for all questions. Score range from 0 to 30. A higher score denotes a more impaired quality of life

Outcome measures

Measure	Olux-E Foam n=17 Participants Olux-E (clobetasol propionate 0.05%) foam	Clobex Lotion n=17 Participants Clobex (clobetasol propionate 0.05%) lotion.
Total Dermatology Life Quality Index (DLQI) Score Day 3	3.75 units on a scale Standard Deviation 2.82	5.76 units on a scale Standard Deviation 4.64
Total Dermatology Life Quality Index (DLQI) Score Day 8	2.65 units on a scale Standard Deviation 3.44	3.29 units on a scale Standard Deviation 3.64
Total Dermatology Life Quality Index (DLQI) Score Day 15	2.12 units on a scale Standard Deviation 3.64	2.41 units on a scale Standard Deviation 3.00

SECONDARY outcome

Timeframe: Days 3, 8, 15

Number of participants who indicated one of the following for total DLQI: 0-1 No effect on the patient's life; 2-5 Small effect on the patient's life; 6-10 Moderate effect on the patient's life; 11-20 Very large effect on the patient's life.

Outcome measures

Measure	Olux-E Foam n=17 Participants Olux-E (clobetasol propionate 0.05%) foam	Clobex Lotion n=17 Participants Clobex (clobetasol propionate 0.05%) lotion.
Dermatology Life Quality Index (DLQI) Categories Day 15 Score 11- 20 Very large effect	1 participants	1 participants
Dermatology Life Quality Index (DLQI) Categories Day 3 Score 0 -1 No effect	5 participants	4 participants
Dermatology Life Quality Index (DLQI) Categories Day 3 Score 2- 5 Small effect	6 participants	4 participants
Dermatology Life Quality Index (DLQI) Categories Day 3 Score 6- 10 Moderate effect	5 participants	7 participants
Dermatology Life Quality Index (DLQI) Categories Day 3 Score 11- 20 Very large effect	0 participants	2 participants
Dermatology Life Quality Index (DLQI) Categories Day 8 Score 0 -1 No effect	9 participants	7 participants
Dermatology Life Quality Index (DLQI) Categories Day 8 Score 2- 5 Small effect	4 participants	6 participants
Dermatology Life Quality Index (DLQI) Categories Day 8 Score 6- 10 Moderate effect	3 participants	3 participants
Dermatology Life Quality Index (DLQI) Categories Day 8 Score 11- 20 Very large effect	1 participants	1 participants
Dermatology Life Quality Index (DLQI) Categories Day 15 Score 0 -1 No effect	11 participants	10 participants
Dermatology Life Quality Index (DLQI) Categories Day 15 Score 2- 5 Small effect	3 participants	5 participants
Dermatology Life Quality Index (DLQI) Categories Day 15 Score 6- 10 Moderate effect	2 participants	1 participants

Adverse Events

Olux-E Foam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clobex Lotion

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Olux-E Foam n=17 participants at risk Olux-E (clobetasol propionate 0.05%) foam	Clobex Lotion n=17 participants at risk Clobex (clobetasol propionate 0.05%) lotion.
Gastrointestinal disorders Nausea	0.00% 0/17 • Baseline through Day 15.	5.9% 1/17 • Number of events 1 • Baseline through Day 15.
Nervous system disorders Dizziness	0.00% 0/17 • Baseline through Day 15.	5.9% 1/17 • Number of events 1 • Baseline through Day 15.
Vascular disorders Hpertension	0.00% 0/17 • Baseline through Day 15.	5.9% 1/17 • Number of events 1 • Baseline through Day 15.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER