A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00415623
• Collaborator: (none)
• Enrollment: 305
• Locations: 15
• Arms: 2
• Duration (Months): 9
• Patients Per Site: 20.3
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

The changes in the trough systolic blood pressure from the baseline were assessed after 8 weeks of double-blind treatment with amlodipine 10 mg or amlodipine 5 mg

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Amlodipine; Drug: Amlodipine	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 305 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Comparative Study Between Amlodipine 5mg And 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Amlodipine 5mg	Drug: Amlodipine; Amlodipine 5mg/ day
Experimental: Amlodipine 10mg	Drug: Amlodipine; Amlodipine 10mg/ day

Outcome Measures

Primary Outcome Measures

1. Change in Systolic Blood Pressure (SBP) From Baseline to Week 8 [Baseline to Week 8]

   Mean change in the trough SBP

Secondary Outcome Measures

1. Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8 [Baseline to Week 8]

   Mean change in the trough DBP

2. Combined Mean Change in SBP From Baseline to Week 6 and Week 8 (Mean by Patient) [Baseline to Week 6 and Week 8]

   Arithmetic mean of Week 6 & Week 8 by patient for "Change from baseline in SBP at Week 6" and "Change from baseline in SBP at Week 8"

3. Combined Mean Change in DBP From Baseline to Week 6 and Week 8 (Mean by Patient) [Baseline to Week 6 and Week 8]

   Arithmetic mean of Week 6 & Week 8 by patient for "Change from baseline in DBP at Week 6" and "Change from baseline in DBP at Week 8"

4. Number of Subjects Achieving the Target Blood Pressure Reduction Value at Week 8 [Week 8]

   Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old

5. Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8 [Week 6 and Week 8]

   Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old

6. Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Week 8 [Week 8]

   Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old

7. Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Both Weeks 6 and 8 [Week 6 and Week 8]

   Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old

8. Trough Plasma Concentrations of Amlodipine -Amlodipine 5 mg [Baseline, Week 4 and Week 8]

9. Trough Plasma Concentrations of Amlodipine -Amlodipine 10 mg [Baseline, Week 4, and Week 8]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Untreated Hypertensive Patients: An systolic blood pressure of >=160 mmHg or diastolic blood pressure >=100mmHg.

• Treated Hypertensive Patients: An systolic blood pressure of >=140 mmHg or diastolic blood pressure of >= 90 mmHg.

• Patients with insufficient response to 5 mg of amlodipine in the screening period:Two successive systolic blood pressure measurements at Visit 4 (Week -2) and Visit 5 (Week 0 = baseline) >=140 mmHg

• Patients with a screening treatment compliance rate >= 80%

Exclusion Criteria:

• Subjects with secondary hypertension (renal disease, pheochromocytoma, and Cushing's syndrome, etc.), severe hypertension (systolic blood pressure of 180 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher), and malignant hypertension

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Kasuya-gun	Fujuoka	Japan
2	Pfizer Investigational Site	Chikushino	Fukuoka	Japan
3	Pfizer Investigational Site	Kitakyushu	Fukuoka	Japan
4	Pfizer Investigational Site	Koga	Fukuoka	Japan
5	Pfizer Investigational Site	Sapporo	Hokkaidou	Japan
6	Pfizer Investigational Site	Sapporo	Hokkaido	Japan
7	Pfizer Investigational Site	Yokohama	Kanagawa	Japan
8	Pfizer Investigational Site	Iruma	Saitama	Japan
9	Pfizer Investigational Site	Koshigaya	Saitama	Japan
10	Pfizer Investigational Site	Adachi-ku	Tokyo	Japan
11	Pfizer Investigational Site	Edogawa-ku	Tokyo	Japan
12	Pfizer Investigational Site	Meguro-ku	Tokyo	Japan
13	Pfizer Investigational Site	Setagaya-ku	Tokyo	Japan
14	Pfizer Investigational Site	Sumida	Tokyo	Japan
15	Pfizer Investigational Site	Fukuoka		Japan

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00415623
• Other Study ID Numbers: A0531085
• First Posted: Dec 25, 2006
• Last Update Posted: Feb 11, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Hypertension; Amlodipine

Study Results

Participant Flow

Recruitment Details	Twenty-four (24) centers in Japan
Pre-assignment Detail	Consent was taken from 414 patients, 356 patients who met the screening criteria received amlodipine 5 mg. After the 8 weeks of screening treatment, patients who met the entry criteria for double-blind period were randomized to either the amlodipine 10 mg group or the amlodipine 5 mg group at a ratio of 1:1.

Arm/Group Title	Amlodipine 5 mg	Amlodipine 10 mg
Arm/Group Description	One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
Period Title: Overall Study
STARTED	154	151
COMPLETED	149	146
NOT COMPLETED	5	5

Baseline Characteristics

Arm/Group Title	Amlodipine 5 mg	Amlodipine 10 mg	Total
Arm/Group Description	One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.	Total of all reporting groups
Overall Participants	154	151	305
Age, Customized (partcipants) [Number]
< 20 years	0	0	0
20 to 44 years	15	15	30
45 to 64 years	75	70	145
>= 65 years	64	66	130
Sex: Female, Male (Count of Participants)
Female	70 45.5%	59 39.1%	129 42.3%
Male	84 54.5%	92 60.9%	176 57.7%
Region of Enrollment (participants) [Number]
Japan	154 100%	151 100%	305 100%

Outcome Measures

1. Primary Outcome

Title	Change in Systolic Blood Pressure (SBP) From Baseline to Week 8
Description	Mean change in the trough SBP
Time Frame	Baseline to Week 8

Outcome Measure Data

Analysis Population Description

Full Analysis Set, Last Observation Carried Forward

Arm/Group Title	Amlodipine 5 mg	Amlodipine 10 mg
Arm/Group Description	One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
Measure Participants	151	150
Least Squares Mean (95% Confidence Interval) [mmHg]	-7.0	-13.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 5 mg, Amlodipine 10 mg
	Comments	The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough SBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.7
	Confidence Interval	() 95%; -9.0 to -4.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8
Description	Mean change in the trough DBP
Time Frame	Baseline to Week 8

Outcome Measure Data

Analysis Population Description

Full Analysis Set, Last Observation Carried Forward

Arm/Group Title	Amlodipine 5 mg	Amlodipine 10 mg
Arm/Group Description	One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
Measure Participants	151	150
Least Squares Mean (95% Confidence Interval) [mmHg]	-2.7	-6.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 5 mg, Amlodipine 10 mg
	Comments	The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough DBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.1
	Confidence Interval	() 95%; -5.7 to -2.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Combined Mean Change in SBP From Baseline to Week 6 and Week 8 (Mean by Patient)
Description	Arithmetic mean of Week 6 & Week 8 by patient for "Change from baseline in SBP at Week 6" and "Change from baseline in SBP at Week 8"
Time Frame	Baseline to Week 6 and Week 8

Outcome Measure Data

Analysis Population Description

Full Analysis Set, Last Observation Carried Forward

Arm/Group Title	Amlodipine 5 mg	Amlodipine 10 mg
Arm/Group Description	One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
Measure Participants	151	150
Least Squares Mean (95% Confidence Interval) [mmHg]	-6.8	-13.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 5 mg, Amlodipine 10 mg
	Comments	The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough SBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-7.1
	Confidence Interval	() 95%; -9.1 to -5.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Combined Mean Change in DBP From Baseline to Week 6 and Week 8 (Mean by Patient)
Description	Arithmetic mean of Week 6 & Week 8 by patient for "Change from baseline in DBP at Week 6" and "Change from baseline in DBP at Week 8"
Time Frame	Baseline to Week 6 and Week 8

Outcome Measure Data

Analysis Population Description

Full Analysis Set, Last Observation Carried Forward

Arm/Group Title	Amlodipine 5 mg	Amlodipine 10 mg
Arm/Group Description	One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
Measure Participants	151	150
Least Squares Mean (95% Confidence Interval) [mmHg]	-2.5	-6.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 5 mg, Amlodipine 10 mg
	Comments	The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough DBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.0
	Confidence Interval	() 95%; -5.4 to -2.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Number of Subjects Achieving the Target Blood Pressure Reduction Value at Week 8
Description	Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Full Analysis Set, Last Observation Carried Forward

Arm/Group Title	Amlodipine 5 mg	Amlodipine 10 mg
Arm/Group Description	One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
Measure Participants	151	150
Number [participants]	43 27.9%	66 43.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 5 mg, Amlodipine 10 mg
	Comments	Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (<=64, >=65) as a factor. The significance level was 0.05 (two-sided).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.33
	Confidence Interval	() 95%; 1.36 to 3.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8
Description	Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old
Time Frame	Week 6 and Week 8

Outcome Measure Data

Analysis Population Description

Full Analysis Set, Last Observation Carried Forward

Arm/Group Title	Amlodipine 5 mg	Amlodipine 10 mg
Arm/Group Description	One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
Measure Participants	151	150
Number [participants]	22 14.3%	52 34.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 5 mg, Amlodipine 10 mg
	Comments	Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (<=64, >=65) as a factor. The significance level was 0.05 (two-sided).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.46
	Confidence Interval	() 95%; 2.28 to 8.74
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Week 8
Description	Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Full Analysis Set, Last Observation Carried Forward

Arm/Group Title	Amlodipine 5 mg	Amlodipine 10 mg
Arm/Group Description	One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
Measure Participants	151	150
Number [participants]	35 22.7%	61 40.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 5 mg, Amlodipine 10 mg
	Comments	Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (<=64, >=65) as a factor. The significance level was 0.05 (two-sided).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.55
	Confidence Interval	() 95%; 1.50 to 4.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Both Weeks 6 and 8
Description	Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old
Time Frame	Week 6 and Week 8

Outcome Measure Data

Analysis Population Description

Full Analysis Set, Last Observation Carried Forward

Arm/Group Title	Amlodipine 5 mg	Amlodipine 10 mg
Arm/Group Description	One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
Measure Participants	151	150
Number [participants]	16 10.4%	44 29.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Amlodipine 5 mg, Amlodipine 10 mg
	Comments	Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (<=64, >=65) as a factor. The significance level was 0.05 (two-sided).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.16
	Confidence Interval	() 95%; 2.12 to 8.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Trough Plasma Concentrations of Amlodipine -Amlodipine 5 mg
Time Frame	Baseline, Week 4 and Week 8

Outcome Measure Data

Analysis Population Description

Plasma concentration obtained after temporarily dosing discontinuation or not matched with the following conditions were excluded from the analysis; Steady-state condition: at least 80% drug compliance from the previous visit to the day of sampling; Trough condition: samples taken within ±10% of 24 hours from last dosing.

Arm/Group Title	Baseline	Week 4	Week 8
Arm/Group Description	After once daily administration of amlodipine 5 mg for 8 weeks in the screening period
Measure Participants	147	146	145
Geometric Mean (95% Confidence Interval) [ng/mL]	7.02	6.83	7.03

10. Secondary Outcome

Title	Trough Plasma Concentrations of Amlodipine -Amlodipine 10 mg
Time Frame	Baseline, Week 4, and Week 8

Outcome Measure Data

Analysis Population Description

Plasma concentration obtained after temporarily dosing discontinuation or not matched with the following conditions were excluded from the analysis; Steady-state condition: at least 80% drug compliance from the previous visit to the day of sampling; Trough condition: samples taken within ±10% of 24 hours from last dosing.

Arm/Group Title	Baseline	Week 4	Week 8
Arm/Group Description	After once daily administration of amlodipine 5 mg for 8 weeks in the screening period
Measure Participants	145	144	143
Geometric Mean (95% Confidence Interval) [ng/mL]	7.18	16.9	16.9

Adverse Events

Limitations/Caveats

[Not Specified]

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 <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.