Study Evaluating Bapineuzumab In Alzheimer Disease Subjects

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00663026
• Collaborator: (none)
• Enrollment: 79
• Locations: 17
• Arms: 3
• Duration (Months): 23
• Patients Per Site: 4.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The study will evaluate the safety and effectiveness of bapineuzumab for the treatment of mild to moderate Alzheimer disease. Subjects will be in the study for six months and will receive subcutaneous injections once per week.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Drug: bapineuzumab; Drug: bapineuzumab; Drug: placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Safety, Tolerability, Reactogenicity, And Pharmacokinetic Study Of Bapineuzumab (AAB 001) Administered Subcutaneously In Subjects With Mild To Moderate AD
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A 5 mg/week	Drug: bapineuzumab; 5 mg bapineuzumab subcutaneous injection once per week for 6 months
Experimental: B 10 mg/week	Drug: bapineuzumab; 10 mg bapineuzumab subcutaneous injection once per week for 6 months
Experimental: C Placebo	Drug: placebo; Placebo subcutaneous injection once per week for 6 months

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to 30 days after Week 25 dose]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after Week 25 dose that were absent before treatment or that worsened relative to pretreatment state.

Secondary Outcome Measures

1. Maximum Observed Serum Concentration (Cmax) [Predose, 4 hours [hrs] postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12]

2. Average Serum Concentration at Steady State (Cavg,ss) [Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12]

   Average plasma concentration at steady state (Cavg,ss) = AUCtau divided by dosing interval (1 week). AUCtau is the area under the plasma concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 1 week.

3. Serum Decay Half-Life (t1/2) [Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12]

   Serum decay half-life is the time measured for the serum concentration to decrease by one half.

4. Time to Reach Maximum Observed Serum Concentration (Tmax) [Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12]

5. Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) [Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12]

   AUCtau is the area under the serum concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 1 week.

6. Apparent Systemic Clearance (CL/F) [Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12]

   Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction (F) of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Steady-state apparent systemic clearance (CL/F) was calculated as dose/AUC tau.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of probable Alzheimer Disease according to National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria

• Mini-Mental State Examination (MMSE) score 16-26

Exclusion Criteria:

• Magnetic Resonance Imaging (MRI) showing other brain abnormalities

• Other diagnosed neurological or psychiatric disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Phoenix	Arizona	United States	85006
2	Pfizer Investigational Site	Sun City	Arizona	United States	85351
3	Pfizer Investigational Site	Encino	California	United States	91316
4	Pfizer Investigational Site	Los Alamitos	California	United States	90720
5	Pfizer Investigational Site	Newport Beach	California	United States	92660
6	Pfizer Investigational Site	Delray Beach	Florida	United States	33445
7	Pfizer Investigational Site	Hallandale	Florida	United States	33009
8	Pfizer Investigational Site	West Palm Beach	Florida	United States	33407
9	Pfizer Investigational Site	Decatur	Georgia	United States	30033
10	Pfizer Investigational Site	Lawrenceville	Georgia	United States	30045
11	Pfizer Investigational Site	Wichita	Kansas	United States	67211
12	Pfizer Investigational Site	Rochester	New York	United States	14620
13	Pfizer Investigational Site	East Providence	Rhode Island	United States	02914
14	Pfizer Investigational Site	Providence	Rhode Island	United States	02906
15	Pfizer Investigational Site	Dallas	Texas	United States	75214
16	Pfizer Investigational Site	Bennington	Vermont	United States	05201
17	Pfizer Investigational Site	Madison	Wisconsin	United States	53705

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00663026
• Other Study ID Numbers: 3133L1-2203; B2521008
• First Posted: Apr 21, 2008
• Last Update Posted: Nov 15, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by Pfizer: antibody; immunotherapy
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

Participant Flow

Arm/Group Title	Placebo	Bapineuzumab 5 mg	Bapineuzumab 10 mg
Arm/Group Description	Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.	Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.	Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
Period Title: Overall Study
STARTED	19	29	31
COMPLETED	17	23	27
NOT COMPLETED	2	6	4

Baseline Characteristics

Arm/Group Title	Placebo	Bapineuzumab 5 mg	Bapineuzumab 10 mg	Total
Arm/Group Description	Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.	Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.	Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.	Total of all reporting groups
Overall Participants	19	29	31	79
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	76.16 (8.63)	71.28 (8.73)	72.42 (8.83)	72.90 (8.85)
Sex: Female, Male (Count of Participants)
Female	8 42.1%	18 62.1%	12 38.7%	38 48.1%
Male	11 57.9%	11 37.9%	19 61.3%	41 51.9%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after Week 25 dose that were absent before treatment or that worsened relative to pretreatment state.
Time Frame	Baseline up to 30 days after Week 25 dose

Outcome Measure Data

Analysis Population Description

Safety population included all randomized participants who received at least 1 dose of study medication.

Arm/Group Title	Placebo	Bapineuzumab 5 mg	Bapineuzumab 10 mg
Arm/Group Description	Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.	Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.	Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
Measure Participants	19	29	31
AEs	16 84.2%	22 75.9%	28 90.3%
SAEs	1 5.3%	2 6.9%	3 9.7%

2. Secondary Outcome

Title	Maximum Observed Serum Concentration (Cmax)
Time Frame	Predose, 4 hours [hrs] postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, time to maximum concentration [tmax], area under the curve [AUC], terminal elimination half-life [t1/2], apparent systemic clearance [CL/F], and apparent volume of distribution [Vz/F]).

Arm/Group Title	Bapineuzumab 5 mg	Bapineuzumab 10 mg
Arm/Group Description	Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.	Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
Measure Participants	29	31
Mean (Standard Deviation) [nanogram per milliliter (ng/mL)]	4219.97 (945.23)	8012.88 (2793.53)

3. Secondary Outcome

Title	Average Serum Concentration at Steady State (Cavg,ss)
Description	Average plasma concentration at steady state (Cavg,ss) = AUCtau divided by dosing interval (1 week). AUCtau is the area under the plasma concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 1 week.
Time Frame	Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12

Outcome Measure Data

Analysis Population Description

PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	Bapineuzumab 5 mg	Bapineuzumab 10 mg
Arm/Group Description	Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.	Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
Measure Participants	25	29
Mean (Standard Deviation) [ng/mL]	3123.071 (1074.116)	6912.301 (2149.143)

4. Secondary Outcome

Title	Serum Decay Half-Life (t1/2)
Description	Serum decay half-life is the time measured for the serum concentration to decrease by one half.
Time Frame	Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12

Outcome Measure Data

Analysis Population Description

t1/2 not calculated due to inadequate characterization of the terminal elimination phase.

Arm/Group Title	Bapineuzumab 5 mg	Bapineuzumab 10 mg
Arm/Group Description	Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.	Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
Measure Participants	0	0

5. Secondary Outcome

Title	Time to Reach Maximum Observed Serum Concentration (Tmax)
Time Frame	Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12

Outcome Measure Data

Analysis Population Description

PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F).

Arm/Group Title	Bapineuzumab 5 mg	Bapineuzumab 10 mg
Arm/Group Description	Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.	Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
Measure Participants	29	31
Median (Full Range) [hours]	3696.00	4200.00

6. Secondary Outcome

Title	Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Description	AUCtau is the area under the serum concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 1 week.
Time Frame	Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12

Outcome Measure Data

Analysis Population Description

PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	Bapineuzumab 5 mg	Bapineuzumab 10 mg
Arm/Group Description	Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.	Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
Measure Participants	25	31
Mean (Standard Deviation) [ng*hr/mL]	524675.88 (180451.56)	1161266.63 (361056.04)

7. Secondary Outcome

Title	Apparent Systemic Clearance (CL/F)
Description	Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction (F) of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Steady-state apparent systemic clearance (CL/F) was calculated as dose/AUC tau.
Time Frame	Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12

Outcome Measure Data

Analysis Population Description

PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	Bapineuzumab 5 mg	Bapineuzumab 10 mg
Arm/Group Description	Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.	Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
Measure Participants	25	29
Mean (Standard Deviation) [milliliter/hour/kilogram (mL/hr/kg)]	0.16 (0.05)	0.132 (0.069)

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Placebo		Bapineuzumab 5 mg		Bapineuzumab 10 mg
Arm/Group Description	Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.		Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.		Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
All Cause Mortality
	Placebo		Bapineuzumab 5 mg		Bapineuzumab 10 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Bapineuzumab 5 mg		Bapineuzumab 10 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/19 (5.3%)		2/29 (6.9%)		3/31 (9.7%)
Cardiac disorders
Atrial fibrillation	0/19 (0%)		0/29 (0%)		1/31 (3.2%)
Immune system disorders
Serum sickness	0/19 (0%)		1/29 (3.4%)		0/31 (0%)
Infections and infestations
Lobar pneumonia	1/19 (5.3%)		0/29 (0%)		0/31 (0%)
Injury, poisoning and procedural complications
Subdural hemorrhage	0/19 (0%)		0/29 (0%)		1/31 (3.2%)
Nervous system disorders
Convulsion	0/19 (0%)		1/29 (3.4%)		0/31 (0%)
Subarachnoid hemorrhage	0/19 (0%)		0/29 (0%)		1/31 (3.2%)
Psychiatric disorders
Delirium	0/19 (0%)		0/29 (0%)		1/31 (3.2%)
Reproductive system and breast disorders
Cystocele	0/19 (0%)		0/29 (0%)		1/31 (3.2%)
Rectocele	0/19 (0%)		0/29 (0%)		1/31 (3.2%)
Other (Not Including Serious) Adverse Events
	Placebo		Bapineuzumab 5 mg		Bapineuzumab 10 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/19 (78.9%)		22/29 (75.9%)		27/31 (87.1%)
Ear and labyrinth disorders
Tympanic membrane perforation	1/19 (5.3%)		0/29 (0%)		0/31 (0%)
Gastrointestinal disorders
Diarrhoea	2/19 (10.5%)		5/29 (17.2%)		2/31 (6.5%)
Dyspepsia	1/19 (5.3%)		2/29 (6.9%)		0/31 (0%)
Gastric haemorrhage	1/19 (5.3%)		0/29 (0%)		0/31 (0%)
Hiatus hernia	1/19 (5.3%)		0/29 (0%)		0/31 (0%)
Nausea	1/19 (5.3%)		2/29 (6.9%)		2/31 (6.5%)
Rectal haemorrhage	0/19 (0%)		0/29 (0%)		2/31 (6.5%)
General disorders
Fatigue	2/19 (10.5%)		2/29 (6.9%)		0/31 (0%)
Injection site erythema	1/19 (5.3%)		2/29 (6.9%)		1/31 (3.2%)
Injection site haemorrhage	1/19 (5.3%)		0/29 (0%)		0/31 (0%)
Injection site pain	1/19 (5.3%)		0/29 (0%)		0/31 (0%)
Vessel puncture site haematoma	1/19 (5.3%)		0/29 (0%)		0/31 (0%)
Immune system disorders
Seasonal allergy	1/19 (5.3%)		0/29 (0%)		0/31 (0%)
Infections and infestations
Nasopharyngitis	2/19 (10.5%)		1/29 (3.4%)		0/31 (0%)
Rhinitis	0/19 (0%)		0/29 (0%)		2/31 (6.5%)
Sinusitis	2/19 (10.5%)		0/29 (0%)		0/31 (0%)
Upper respiratory tract infection	2/19 (10.5%)		1/29 (3.4%)		6/31 (19.4%)
Urinary tract infection	2/19 (10.5%)		1/29 (3.4%)		1/31 (3.2%)
Injury, poisoning and procedural complications
Arthropod bite	1/19 (5.3%)		0/29 (0%)		0/31 (0%)
Contusion	1/19 (5.3%)		3/29 (10.3%)		2/31 (6.5%)
Fall	0/19 (0%)		1/29 (3.4%)		2/31 (6.5%)
Tendon rupture	1/19 (5.3%)		1/29 (3.4%)		0/31 (0%)
Investigations
Blood cholesterol increased	1/19 (5.3%)		0/29 (0%)		0/31 (0%)
Weight decreased	1/19 (5.3%)		1/29 (3.4%)		1/31 (3.2%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/19 (5.3%)		1/29 (3.4%)		0/31 (0%)
Back pain	1/19 (5.3%)		2/29 (6.9%)		1/31 (3.2%)
Myalgia	1/19 (5.3%)		1/29 (3.4%)		1/31 (3.2%)
Neck pain	1/19 (5.3%)		0/29 (0%)		1/31 (3.2%)
Osteoarthritis	1/19 (5.3%)		0/29 (0%)		0/31 (0%)
Polyarthritis	1/19 (5.3%)		0/29 (0%)		0/31 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Atypical fibroxanthoma	1/19 (5.3%)		0/29 (0%)		0/31 (0%)
Nervous system disorders
Dizziness	2/19 (10.5%)		2/29 (6.9%)		2/31 (6.5%)
Headache	2/19 (10.5%)		2/29 (6.9%)		2/31 (6.5%)
Paraesthesia	1/19 (5.3%)		0/29 (0%)		0/31 (0%)
Somnolence	1/19 (5.3%)		0/29 (0%)		0/31 (0%)
Vasogenic cerebral oedema	0/19 (0%)		2/29 (6.9%)		6/31 (19.4%)
Psychiatric disorders
Agitation	0/19 (0%)		2/29 (6.9%)		0/31 (0%)
Anxiety	1/19 (5.3%)		1/29 (3.4%)		1/31 (3.2%)
Depression	1/19 (5.3%)		0/29 (0%)		0/31 (0%)
Hallucination	0/19 (0%)		2/29 (6.9%)		0/31 (0%)
Insomnia	0/19 (0%)		2/29 (6.9%)		1/31 (3.2%)
Respiratory, thoracic and mediastinal disorders
Cough	2/19 (10.5%)		0/29 (0%)		0/31 (0%)
Epistaxis	1/19 (5.3%)		1/29 (3.4%)		0/31 (0%)
Rhinitis allergic	0/19 (0%)		0/29 (0%)		2/31 (6.5%)
Skin and subcutaneous tissue disorders
Psoriasis	1/19 (5.3%)		0/29 (0%)		0/31 (0%)
Rash	1/19 (5.3%)		0/29 (0%)		0/31 (0%)
Rash papular	1/19 (5.3%)		0/29 (0%)		1/31 (3.2%)
Vascular disorders
Orthostatic hypotension	1/19 (5.3%)		0/29 (0%)		0/31 (0%)

Limitations/Caveats

Designation of outcomes as primary, secondary was based on study team's input as study did not specify them as primary or secondary.

More Information

Certain Agreements

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

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.