Safety and Efficacy of ATG003 in Patients With Wet Age-Re... | NCT00414206

Status Module

Label	Type	Intervention Names
1% mecamylamine	Active Comparator	Drug: Mecamylamine
0.3% mecamylamine	Active Comparator	Drug: Mecamylamine
Placebo	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Mecamylamine	Drug		0.3% mecamylamine 1% mecamylamine
Placebo

Measure	Description	Time Frame
Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline.		Baseline to Week 48

Name	Affiliation	Role
Carl Grove	CoMentis	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Olhos de Araraquara		Araraquara			Brazil
Centro Brasileiro de Ciências Visuais

Label	URL
Related Info	View source

Results Section

Participant Flow Module

ID	Title	Description
FG000	1% Mecamylamine
FG001	0.3% Mecamylamine
FG002	Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline.

A modified MITT population was used, which was prospectively defined as all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy (visual acuity) assessment.

Posted

Number

Percent of subjects

Baseline to Week 48

ID	Title	Description
OG000	1% Mecamylamine
OG001	0.3% Mecamylamine
OG002	Placebo

Units	Counts
Participants	OG000113 OG001112 OG002113

Title

Denominators

Categories

Title	Measurements
	OG00088 OG00186 OG00292

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002		ANCOVA		>0.05													No	Superiority or Other

Serious Adverse Events

Term	Organ System	Statistical Information
Anaemia	Blood and lymphatic system disorders	EG0000 events0 affected115 at risk EG0011 events1 affected115 at risk EG0020 events0 affected114 at risk
Atrial fibrillation	Cardiac disorders	EG0001 events1 affected115 at risk EG0011 events1 affected115 at risk EG0020 events0 affected114 at risk
Acute myocardial infarction	Cardiac disorders	EG0000 events0 affected115 at risk EG0010 events0 affected115 at risk EG0021 events1 affected114 at risk
Atrioventricular block	Cardiac disorders	EG0000 events0 affected115 at risk EG0011 events1 affected115 at risk EG0020 events0 affected114 at risk
Cardiac failure	Cardiac disorders	EG0000 events0 affected115 at risk EG0011 events1 affected115 at risk EG0020 events0 affected114 at risk
Myocardial ischaemia	Cardiac disorders	EG0000 events0 affected115 at risk EG0010 events0 affected115 at risk EG0021 events1 affected114 at risk
Retinal haemorrhage	Eye disorders	EG0001 events1 affected115 at risk EG0011 events1 affected115 at risk EG0020 events0 affected114 at risk
Retinal detachment	Eye disorders	EG0001 events1 affected115 at risk EG0010 events0 affected115 at risk EG0020 events0 affected114 at risk
Vitreous haemorrhage	Eye disorders	EG0000 events0 affected115 at risk EG0011 events1 affected115 at risk EG0020 events0 affected114 at risk
Diarrhoea	Gastrointestinal disorders	EG0000 events0 affected115 at risk EG0010 events0 affected115 at risk EG0021 events1 affected114 at risk
Duodenal ucler	General disorders	EG0000 events0 affected115 at risk EG0010 events0 affected115 at risk EG0021 events1 affected114 at risk
Reflux gastritis	Gastrointestinal disorders	EG0000 events0 affected115 at risk EG0011 events1 affected115 at risk EG0020 events0 affected114 at risk
Cholelithiasis obstructive	Hepatobiliary disorders	EG0000 events0 affected115 at risk EG0011 events1 affected115 at risk EG0020 events0 affected114 at risk
Pneumonia	Infections and infestations	EG0000 events0 affected115 at risk EG0012 events2 affected115 at risk EG0020 events0 affected114 at risk
Diverticulitis	Infections and infestations	EG0001 events1 affected115 at risk EG0010 events0 affected115 at risk EG0020 events0 affected114 at risk
Clavicle fracture	Injury, poisoning and procedural complications	EG0000 events0 affected115 at risk EG0010 events0 affected115 at risk EG0021 events1 affected114 at risk
Tibia fracture	Injury, poisoning and procedural complications	EG0001 events1 affected115 at risk EG0010 events0 affected115 at risk EG0020 events0 affected114 at risk
Cerebrovascular accident	Nervous system disorders	EG0002 events2 affected115 at risk EG0010 events0 affected115 at risk EG0020 events0 affected114 at risk
Cerebral infarction	Nervous system disorders	EG0001 events1 affected115 at risk EG0010 events0 affected115 at risk EG0020 events0 affected114 at risk
Calculus bladder	Renal and urinary disorders	EG0000 events0 affected115 at risk EG0010 events0 affected115 at risk EG0021 events1 affected114 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	EG0000 events0 affected115 at risk EG0011 events1 affected115 at risk EG0020 events0 affected114 at risk
Hypertensive crisis	Vascular disorders	EG0000 events0 affected115 at risk EG0010 events0 affected115 at risk EG0021 events1 affected114 at risk

Other Adverse Events

Term	Organ System	Statistical Information
Cardiac disorders	Cardiac disorders	EG0004 events4 affected115 at risk EG0018 events8 affected114 at risk EG0024 events4 affected114 at risk
Visual acuity reduced	Eye disorders	EG00038 events38 affected115 at risk EG00131 events31 affected114 at risk EG00238 events38 affected114 at risk
Retinal haemorrhage	Eye disorders	EG00017 events17 affected115 at risk EG00111 events11 affected114 at risk EG00216 events16 affected114 at risk
Cataract	Eye disorders	EG0007 events7 affected115 at risk EG0010 events0 affected114 at risk EG0021 events1 affected114 at risk
Gastrointestinal disorders	Gastrointestinal disorders	EG0009 events9 affected115 at risk EG0015 events5 affected114 at risk EG0028 events8 affected114 at risk
Infections and Infestiations	Infections and infestations	EG00019 events19 affected115 at risk EG00116 events16 affected114 at risk EG00212 events12 affected114 at risk
Investigations	Investigations	EG0004 events4 affected115 at risk EG0016 events6 affected114 at risk EG0027 events7 affected114 at risk
Musculoskeletal and connective tissue disorders	Musculoskeletal and connective tissue disorders	EG0008 events8 affected115 at risk EG0015 events5 affected114 at risk EG0024 events4 affected114 at risk
Nervous system disorders	Nervous system disorders	EG00015 events15 affected115 at risk EG0012 events2 affected114 at risk EG0029 events9 affected114 at risk
Headache	Nervous system disorders	EG0006 events6 affected115 at risk EG0012 events2 affected114 at risk EG0024 events4 affected114 at risk
Vascular disorders	Vascular disorders	EG0006 events6 affected115 at risk EG0013 events3 affected114 at risk EG0026 events6 affected114 at risk

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

ID	Term
D009636	Norbornanes
D001643	Bridged Bicyclo Compounds
D001952	Bridged-Ring Compounds
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds

ID	Title	Description
BG000	1% Mecamylamine
BG001	0.3% Mecamylamine
BG002	Placebo
BG003	Total	Total of all reporting groups

ID	Title	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	1% Mecamylamine	8	115	68	115
EG001	0.3% Mecamylamine	8	115	57	114
EG002	Placebo	7	114	57	114