Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)

• Sponsor: FUJIFILM Toyama Chemical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02079909
• Collaborator: Alzheimer's Disease Cooperative Study (ADCS) (Other)
• Enrollment: 482
• Locations: 50
• Arms: 3
• Duration (Months): 38.1
• Patients Per Site: 9.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The primary objective is to evaluate the efficacy of T-817MA as measured by ADAS-cog and ADCS-CGIC.

The secondary objectives are:

• To evaluate the safety and tolerability of T-817MA measured by clinical safety laboratories, physical examinations, ECGs and solicitation of adverse events.

• To evaluate the efficacy of T-817MA as measured by ADCS-ADL, FAQ, Neuropsychiatric Inventory (NPI) and Mini-mental State Examination (MMSE).

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Drug: T-817MA-H; Drug: T-817MA-L; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 482 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Multi-center, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: May 5, 2017
• Actual Study Completion Date: May 5, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: T-817MA-H 224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.	Drug: T-817MA-H; 224 mg or 448 mg T-817 MA once daily
Experimental: T-817MA-L 224 mg T-817MA once daily	Drug: T-817MA-L; 224 mg T-817 MA once daily
Placebo Comparator: Placebo Placebo once daily	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. ADAS-cog Change From Baseline to Week 52 [Baseline and 52 weeks]

   The ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) is a structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained. The test is scored in terms of errors, with higher scores reflecting poorer performance and greater impairment. Scores can range from 0 (best) to 70 (worse).

2. CGIC [52 weeks]

   The ADCS-CGIC (Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change) is a validated categorical measure of change in the patient's clinical condition between baseline and follow-up visits. It measures whether the effects of active treatment are substantial enough to be detected by a skilled and experienced clinician on the basis of a clinical interview and examination. It relies on both direct examination of the patient and an interview of the study partner. A skilled and experienced clinician who is blinded to treatment assignment rates the patient on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). It is suggested that the instrument has distinct clinical utility in assessing change in AD clinical trials.

Secondary Outcome Measures

1. ADCS-ADL Change From Baseline to Week 52 [Baseline and 52 weeks]

   The ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) is a validated tool for assessing instrumental and basic activities of daily living based on a 23-item structured interview of the study partner. The scale has a range of 0 to 78, with lower scores indicating greater impairment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female (post-menopausal or surgically sterile)

• Patients with Mild to moderate Alzheimer's disease who are receiving donepezil (Aricept®) or rivastigmine transdermal system (Exelon® Patch), . Memantine (Namenda®) is allowed only when prescribed in combination with donepezil or rivastigmine transdermal system.

• Age 55 to 85 inclusive

• Patients must be living in the community

• Patients must have an eligible informant or study partner (caregiver)

• Patients and eligible informant or study partner (caregiver) must be able to read and understand English.

• Informed consent obtained from both the patient and the caregiver

Exclusion Criteria:

• Patients with clinically significant cardiac, hepatic or renal impairment

• Patient have a dementia not of the Alzheimer's type etc (According to the protocol)

• Patients who are taking any drug other than donepezil or rivastigmine transdermal system for Alzheimer's disease, including olal rivastigmine (Exelon®), galantamine (Razadyne®)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banner Alzheimer's Institute	Phoenix	Arizona	United States
2	Banner Sun Health Research Institute	Sun City	Arizona	United States
3	University of Arizona Health Sciences Center	Tucson	Arizona	United States
4	Neurology Center of North Orange County	Fullerton	California	United States
5	UCSD Comprehensive Alzheimer's Program	La Jolla	California	United States
6	UC Irvine Medical Center	Orange	California	United States
7	Geriatric and Adult Psychiatry, LCC	Hamden	Connecticut	United States
8	Yale University, Alzheimer's Disease Research Unit	New Haven	Connecticut	United States
9	Research Center for Clinical Studies, Inc.	Norwalk	Connecticut	United States
10	Georgetown University Clinical Research Unit	Washington	District of Columbia	United States
11	Infinity Clinical Research, LLC	Hollywood	Florida	United States
12	University of Miami Miller-School of Medicine	Miami	Florida	United States
13	Scientific Clinical Research, Inc	North Miami	Florida	United States
14	Renstar Medical Research	Ocala	Florida	United States
15	Meridien Research	Tampa	Florida	United States
16	Neuro Trials Research, Inc	Atlanta	Georgia	United States
17	Rush University Medical Center	Chicago	Illinois	United States
18	SIU School of Medicine	Springfield	Illinois	United States
19	Indiana Medical Research	Elkhart	Indiana	United States
20	Indiana University Health Partners, Adult Neurology Clinic	Indianapolis	Indiana	United States
21	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States
22	University of Kansas/Clinical and Translational Science Unit	Fairway	Kansas	United States
23	University of Kentucky Sanders-Brown Center on Aging Clinic	Lexington	Kentucky	United States
24	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States
25	Acadia Hospital	Bangor	Maine	United States
26	Boston University Alzheimer's Disease Center	Boston	Massachusetts	United States
27	University of Michigan Health System/ Michigan Clinical Research Unit	Ann Arbor	Michigan	United States
28	Michigan State University	East Lansing	Michigan	United States
29	Bronson Neurobehvioral Health	Paw Paw	Michigan	United States
30	University of Nebraska Medical Center(Geri Psych)	Omaha	Nebraska	United States
31	Cleveland Clinic Lou Ruvo Center for Brain Health	Las Vegas	Nevada	United States
32	Global Medical Institutes, LLC;Princeton Medical Institute	Princeton	New Jersey	United States
33	Dent Neurologic Institute	Amherst	New York	United States
34	Alzheimer's Disease Research Center of Mount Sinai	New York	New York	United States
35	Columbia University Medical Center Sergievsky Center Taub Institute	New York	New York	United States
36	The Nathan S. Kline Instituite for Psychiatric Research	Orangeburg	New York	United States
37	University of Rochester Medical Center	Rochester	New York	United States
38	SUNY Upstate Medical University	Syracuse	New York	United States
39	Wake Forest University (WFU) School of Medicine	Winston-Salem	North Carolina	United States
40	Case Western Reserve University/ University Hospitals Case Medical Center	Beachwood	Ohio	United States
41	Tulsa Clinical Research, LLC	Tulsa	Oklahoma	United States
42	Hospital at the University of Pennsylvania, Penn Memory Center	Philadelphia	Pennsylvania	United States
43	University of Pittsburgh, Alzheimer Disease Research Center	Pittsburgh	Pennsylvania	United States
44	Abington Neurological Associates, LTD.	Willow Grove	Pennsylvania	United States
45	Roper St. Francis Healthcare	Charleston	South Carolina	United States
46	Vanderbilt University Medical Center -VUIIS	Nashville	Tennessee	United States
47	University of North Texas Health Science Center	Fort Worth	Texas	United States
48	Houston Methodist Hospital	Houston	Texas	United States
49	University of Wisconsin Hospital and Clinics	Madison	Wisconsin	United States
50	Cary J. Kohlenberg MD., SC dba IPC Research	Waukesha	Wisconsin	United States

Sponsors and Collaborators

• FUJIFILM Toyama Chemical Co., Ltd.
• Alzheimer's Disease Cooperative Study (ADCS)

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 12, 2018

More Information

Publications

None provided.

• Responsible Party: FUJIFILM Toyama Chemical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02079909
• Other Study ID Numbers: T817MAUS202
• First Posted: Mar 6, 2014
• Last Update Posted: Feb 26, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by FUJIFILM Toyama Chemical Co., Ltd.: Alzheimer's Disease; Alzheimer's
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

Participant Flow

Arm/Group Title	T-817MA-H	T-817MA-L	Placebo
Arm/Group Description	224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks. T-817MA-H: 224 mg or 448 mg T-817 MA once daily	224 mg T-817MA once daily T-817MA-L: 224 mg T-817 MA once daily	Placebo once daily Placebo: Placebo
Period Title: Overall Study
STARTED	158	166	158
COMPLETED	120	117	140
NOT COMPLETED	38	49	18

Baseline Characteristics

Arm/Group Title	T-817MA-H	T-817MA-L	Placebo	Total
Arm/Group Description	224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks. T-817MA-H: 224 mg or 448 mg T-817 MA once daily	224 mg T-817MA once daily T-817MA-L: 224 mg T-817 MA once daily	Placebo once daily Placebo: Placebo	Total of all reporting groups
Overall Participants	154	159	156	469
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.8 (7.8)	71.9 (8.2)	71.8 (7.5)	71.9 (7.8)
Sex: Female, Male (Count of Participants)
Female	82 53.2%	81 50.9%	89 57.1%	252 53.7%
Male	72 46.8%	78 49.1%	67 42.9%	217 46.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 0.6%	0 0%	1 0.2%
Asian	3 1.9%	3 1.9%	2 1.3%	8 1.7%
Native Hawaiian or Other Pacific Islander	1 0.6%	0 0%	0 0%	1 0.2%
Black or African American	8 5.2%	7 4.4%	11 7.1%	26 5.5%
White	140 90.9%	146 91.8%	142 91%	428 91.3%
More than one race	0 0%	1 0.6%	1 0.6%	2 0.4%
Unknown or Not Reported	2 1.3%	1 0.6%	0 0%	3 0.6%
ApoE4 genotype (Count of Participants)
Non-carriers	54 35.1%	57 35.8%	50 32.1%	161 34.3%
Heterozygotes	55 35.7%	74 46.5%	71 45.5%	200 42.6%
Homozygotes	32 20.8%	21 13.2%	27 17.3%	80 17.1%
Unknown	13 8.4%	7 4.4%	8 5.1%	28 6%
MMSE (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	18.4 (3.9)	18.2 (3.8)	18.2 (3.8)	18.3 (3.8)

Outcome Measures

1. Primary Outcome

Title	ADAS-cog Change From Baseline to Week 52
Description	The ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) is a structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained. The test is scored in terms of errors, with higher scores reflecting poorer performance and greater impairment. Scores can range from 0 (best) to 70 (worse).
Time Frame	Baseline and 52 weeks

Outcome Measure Data

Analysis Population Description

The overall number of participants display the numbers of patients who were included in the mITT population and had baseline and at least one post-baseline ADAS-cog evaluation.

Arm/Group Title	T-817MA-H	T-817MA-L	Placebo
Arm/Group Description	224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks. T-817MA-H: 224 mg or 448 mg T-817 MA once daily	224 mg T-817MA once daily T-817MA-L: 224 mg T-817 MA once daily	Placebo once daily Placebo: Placebo
Measure Participants	117	115	137
Mean (Standard Error) [units on a scale]	7.08 (0.756)	7.45 (0.756)	7.91 (0.727)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	T-817MA-H, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.3919
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.84
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	CGIC
Description	The ADCS-CGIC (Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change) is a validated categorical measure of change in the patient's clinical condition between baseline and follow-up visits. It measures whether the effects of active treatment are substantial enough to be detected by a skilled and experienced clinician on the basis of a clinical interview and examination. It relies on both direct examination of the patient and an interview of the study partner. A skilled and experienced clinician who is blinded to treatment assignment rates the patient on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). It is suggested that the instrument has distinct clinical utility in assessing change in AD clinical trials.
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

The overall number of participants display the numbers of patients who were included in the mITT population and had at least one post-baseline CGIC evaluation.

Arm/Group Title	T-817MA-H	T-817MA-L	Placebo
Arm/Group Description	224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks. T-817MA-H: 224 mg or 448 mg T-817 MA once daily	224 mg T-817MA once daily T-817MA-L: 224 mg T-817 MA once daily	Placebo once daily Placebo: Placebo
Measure Participants	118	116	138
Mean (Standard Error) [units on a scale]	5.25 (0.1)	5.24 (0.1)	5.22 (0.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	T-817MA-H, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.7588
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.04
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	ADCS-ADL Change From Baseline to Week 52
Description	The ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) is a validated tool for assessing instrumental and basic activities of daily living based on a 23-item structured interview of the study partner. The scale has a range of 0 to 78, with lower scores indicating greater impairment.
Time Frame	Baseline and 52 weeks

Outcome Measure Data

Analysis Population Description

The overall number of participants display the numbers of patients who were included in the mITT population and had baseline and at least one post-baseline ADCS-ADL evaluation.

Arm/Group Title	T-817MA-H	T-817MA-L	Placebo
Arm/Group Description	224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks. T-817MA-H: 224 mg or 448 mg T-817 MA once daily	224 mg T-817MA once daily T-817MA-L: 224 mg T-817 MA once daily	Placebo once daily Placebo: Placebo
Measure Participants	118	118	140
Mean (Standard Error) [units on a scale]	-10.01 (0.991)	-11.07 (0.992)	-11.29 (0.957)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	T-817MA-H, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.3212
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.29
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	52weeks
Arm/Group Title	T-817MA-H		T-817MA-L		Placebo
Arm/Group Description	224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks. T-817MA-H: 224 mg or 448 mg T-817 MA once daily		224 mg T-817MA once daily T-817MA-L: 224 mg T-817 MA once daily		Placebo once daily Placebo: Placebo
All Cause Mortality
	T-817MA-H		T-817MA-L		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/158 (1.3%)		2/166 (1.2%)		0/158 (0%)
Serious Adverse Events
	T-817MA-H		T-817MA-L		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	26/158 (16.5%)		25/166 (15.1%)		20/158 (12.7%)
Blood and lymphatic system disorders
Anaemia Macrocytic	1/158 (0.6%)		0/166 (0%)		0/158 (0%)
Cardiac disorders
Acute Myocardial Infarction	0/158 (0%)		0/166 (0%)		1/158 (0.6%)
Atrial Fibrillation	0/158 (0%)		0/166 (0%)		1/158 (0.6%)
Atrioventricular Block Complete	0/158 (0%)		0/166 (0%)		1/158 (0.6%)
Bradycardia	1/158 (0.6%)		0/166 (0%)		0/158 (0%)
Cardiac Arrest	1/158 (0.6%)		0/166 (0%)		0/158 (0%)
Myocardial Infarction	1/158 (0.6%)		1/166 (0.6%)		1/158 (0.6%)
Ear and labyrinth disorders
Vertigo Positional	1/158 (0.6%)		0/166 (0%)		0/158 (0%)
Gastrointestinal disorders
Diarrhoea	0/158 (0%)		1/166 (0.6%)		0/158 (0%)
Duodenal Ulcer Haemorrhage	0/158 (0%)		1/166 (0.6%)		0/158 (0%)
Megacolon	1/158 (0.6%)		0/166 (0%)		0/158 (0%)
Pancreatitis	0/158 (0%)		1/166 (0.6%)		0/158 (0%)
Pancreatitis Acute	0/158 (0%)		1/166 (0.6%)		0/158 (0%)
General disorders
Asthenia	0/158 (0%)		1/166 (0.6%)		0/158 (0%)
Chest Pain	0/158 (0%)		2/166 (1.2%)		1/158 (0.6%)
Non-Cardiac Chest Pain	0/158 (0%)		0/166 (0%)		1/158 (0.6%)
Hepatobiliary disorders
Cholelithiasis	1/158 (0.6%)		0/166 (0%)		0/158 (0%)
Hepatitis	1/158 (0.6%)		0/166 (0%)		0/158 (0%)
Infections and infestations
Cellulitis	2/158 (1.3%)		0/166 (0%)		0/158 (0%)
Clostridium Difficile Infection	0/158 (0%)		1/166 (0.6%)		0/158 (0%)
Cystitis	0/158 (0%)		0/166 (0%)		1/158 (0.6%)
Diverticulitis	1/158 (0.6%)		1/166 (0.6%)		0/158 (0%)
Gastroenteritis	1/158 (0.6%)		0/166 (0%)		0/158 (0%)
Pneumonia	0/158 (0%)		0/166 (0%)		1/158 (0.6%)
Pneumonia Influenzal	1/158 (0.6%)		0/166 (0%)		0/158 (0%)
Sepsis	0/158 (0%)		2/166 (1.2%)		0/158 (0%)
Urinary Tract Infection	2/158 (1.3%)		1/166 (0.6%)		1/158 (0.6%)
Injury, poisoning and procedural complications
Fall	0/158 (0%)		1/166 (0.6%)		0/158 (0%)
Femoral Neck Fracture	1/158 (0.6%)		0/166 (0%)		0/158 (0%)
Femur Fracture	1/158 (0.6%)		1/166 (0.6%)		0/158 (0%)
Hip Fracture	0/158 (0%)		1/166 (0.6%)		1/158 (0.6%)
Humerus Fracture	0/158 (0%)		0/166 (0%)		1/158 (0.6%)
Joint Injury	0/158 (0%)		1/166 (0.6%)		0/158 (0%)
Laceration	0/158 (0%)		0/166 (0%)		1/158 (0.6%)
Multiple Fractures	1/158 (0.6%)		0/166 (0%)		0/158 (0%)
Post Procedural Haemorrhage	0/158 (0%)		1/166 (0.6%)		0/158 (0%)
Rib Fracture	0/158 (0%)		1/166 (0.6%)		0/158 (0%)
Subdural Haematoma	0/158 (0%)		0/166 (0%)		1/158 (0.6%)
Metabolism and nutrition disorders
Dehydration	2/158 (1.3%)		2/166 (1.2%)		0/158 (0%)
Hypokalaemia	1/158 (0.6%)		0/166 (0%)		0/158 (0%)
Musculoskeletal and connective tissue disorders
Chondrocalcinosis Pyrophosphate	1/158 (0.6%)		0/166 (0%)		0/158 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of Colon	0/158 (0%)		0/166 (0%)		1/158 (0.6%)
Breast Cancer	0/158 (0%)		1/166 (0.6%)		0/158 (0%)
Breast Cancer Metastatic	0/158 (0%)		1/166 (0.6%)		0/158 (0%)
Nervous system disorders
Altered State of Consciousness	0/158 (0%)		0/166 (0%)		1/158 (0.6%)
Cerebral Haematoma	0/158 (0%)		1/166 (0.6%)		0/158 (0%)
Cerebral Haemorrhage	0/158 (0%)		1/166 (0.6%)		0/158 (0%)
Cerebrovascular Accident	0/158 (0%)		1/166 (0.6%)		0/158 (0%)
Hydrocephalus	0/158 (0%)		1/166 (0.6%)		0/158 (0%)
Loss of Consciousness	1/158 (0.6%)		0/166 (0%)		0/158 (0%)
Syncope	0/158 (0%)		2/166 (1.2%)		3/158 (1.9%)
Transient Ischaemic Attack	1/158 (0.6%)		0/166 (0%)		0/158 (0%)
Psychiatric disorders
Abnormal Behaviour	0/158 (0%)		0/166 (0%)		1/158 (0.6%)
Agitation	0/158 (0%)		0/166 (0%)		1/158 (0.6%)
Completed Suicide	1/158 (0.6%)		0/166 (0%)		0/158 (0%)
Confusional State	1/158 (0.6%)		1/166 (0.6%)		0/158 (0%)
Delirium	3/158 (1.9%)		1/166 (0.6%)		1/158 (0.6%)
Mental Status Changes	1/158 (0.6%)		0/166 (0%)		0/158 (0%)
Paranoia	1/158 (0.6%)		0/166 (0%)		0/158 (0%)
Renal and urinary disorders
Renal Failure	0/158 (0%)		1/166 (0.6%)		0/158 (0%)
Urinary Retention	0/158 (0%)		1/166 (0.6%)		0/158 (0%)
Reproductive system and breast disorders
Vaginal Haemorrhage	0/158 (0%)		1/166 (0.6%)		0/158 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism	0/158 (0%)		0/166 (0%)		1/158 (0.6%)
Pulmonary Oedema	0/158 (0%)		0/166 (0%)		1/158 (0.6%)
Other (Not Including Serious) Adverse Events
	T-817MA-H		T-817MA-L		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	132/158 (83.5%)		133/166 (80.1%)		119/158 (75.3%)
Gastrointestinal disorders
Diarrhoea	49/158 (31%)		34/166 (20.5%)		20/158 (12.7%)
Nausea	9/158 (5.7%)		13/166 (7.8%)		6/158 (3.8%)
Vomiting	9/158 (5.7%)		8/166 (4.8%)		7/158 (4.4%)
Infections and infestations
Nasopharyngitis	4/158 (2.5%)		4/166 (2.4%)		9/158 (5.7%)
Urinary tract infection	21/158 (13.3%)		17/166 (10.2%)		22/158 (13.9%)
Injury, poisoning and procedural complications
Fall	12/158 (7.6%)		14/166 (8.4%)		17/158 (10.8%)
Investigations
Weight decreased	8/158 (5.1%)		4/166 (2.4%)		3/158 (1.9%)
Nervous system disorders
Dizziness	11/158 (7%)		7/166 (4.2%)		3/158 (1.9%)
Headache	9/158 (5.7%)		16/166 (9.6%)		10/158 (6.3%)
Psychiatric disorders
Agitation	4/158 (2.5%)		5/166 (3%)		14/158 (8.9%)
Anxiety	7/158 (4.4%)		9/166 (5.4%)		12/158 (7.6%)
Depression	8/158 (5.1%)		6/166 (3.6%)		7/158 (4.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.