A Comparative Study Between Amlodipine 10mg And 5mg With... | NCT00415623

A Comparative Study Between Amlodipine 10mg And 5mg With... | NCT00415623 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
Amlodipine 5mg	Active Comparator		Drug: Amlodipine
Amlodipine 10mg	Experimental		Drug: Amlodipine

Name	Type	Description	Arm Group Labels	Other Names
Amlodipine	Drug	Amlodipine 5mg/ day	Amlodipine 5mg
Amlodipine

Outcomes Module

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

Secondary Outcomes

Measure	Description	Time Frame
Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8	Mean change in the trough DBP	Baseline to Week 8
Combined Mean Change in SBP From Baseline to Week 6 and Week 8 (Mean by Patient)

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Kasuya-gun	Fujuoka		Japan
Pfizer Investigational Site

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Amlodipine 5 mg	One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
FG001	Amlodipine 10 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

No data available

No data is available for this block.

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Amlodipine 5 mg	One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
BG001	Amlodipine 10 mg	Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000154 BG001151 BG002305

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

partcipants

Title

Denominators

Categories

< 20 years

Title	Measurements
	BG0000 BG0010 BG0020

20 to 44 years

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00070 BG00159 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Japan

Title	Measurements
	BG000154 BG001151 BG002

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

Change in Systolic Blood Pressure (SBP) From Baseline to Week 8

Mean change in the trough SBP

Full Analysis Set, Last Observation Carried Forward

Posted

Least Squares Mean

95% Confidence Interval

mmHg

Baseline to Week 8

ID	Title	Description
OG000	Amlodipine 5 mg	One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
OG001	Amlodipine 10 mg	Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.

Units	Counts
Participants	OG000151 OG001150

Title

Denominators

Categories

Title	Measurements
	OG000-7.0(-8.8 to -5.2) OG001-13.7(-15.4 to -12.0)

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	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).	ANCOVA		<0.001		Mean Difference (Final Values)	-6.7				95	-9.0	-4.4					Superiority or Other (legacy)

Secondary

Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8

Mean change in the trough DBP

Full Analysis Set, Last Observation Carried Forward

Posted

Least Squares Mean

95% Confidence Interval

mmHg

Baseline to Week 8

ID	Title	Description
OG000	Amlodipine 5 mg	One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
OG001	Amlodipine 10 mg	Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.

Units	Counts
Participants	OG000

Secondary

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

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"

Full Analysis Set, Last Observation Carried Forward

Posted

Least Squares Mean

95% Confidence Interval

mmHg

Baseline to Week 6 and Week 8

ID	Title	Description
OG000	Amlodipine 5 mg	One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
OG001	Amlodipine 10 mg	Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.

Units	Counts
Participants	OG000

Secondary

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

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"

Full Analysis Set, Last Observation Carried Forward

Posted

Least Squares Mean

95% Confidence Interval

mmHg

Baseline to Week 6 and Week 8

ID	Title	Description
OG000	Amlodipine 5 mg	One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
OG001	Amlodipine 10 mg	Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.

Units	Counts
Participants	OG000

Secondary

Number of Subjects Achieving the Target Blood Pressure Reduction Value at 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

Full Analysis Set, Last Observation Carried Forward

Posted

Number

participants

Week 8

ID	Title	Description
OG000	Amlodipine 5 mg	One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
OG001	Amlodipine 10 mg	Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.

Units	Counts
Participants	OG000

Secondary

Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8

Full Analysis Set, Last Observation Carried Forward

Posted

Number

participants

Week 6 and Week 8

ID	Title	Description
OG000	Amlodipine 5 mg	One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
OG001	Amlodipine 10 mg	Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.

Units	Counts
Participants	OG000

Secondary

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

Full Analysis Set, Last Observation Carried Forward

Posted

Number

participants

Week 8

ID	Title	Description
OG000	Amlodipine 5 mg	One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
OG001	Amlodipine 10 mg	Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.

Units	Counts
Participants	OG000

Secondary

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

Full Analysis Set, Last Observation Carried Forward

Posted

Number

participants

Week 6 and Week 8

ID	Title	Description
OG000	Amlodipine 5 mg	One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
OG001	Amlodipine 10 mg	Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.

Units	Counts
Participants	OG000

Secondary

Trough Plasma Concentrations of Amlodipine -Amlodipine 5 mg

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.

Posted

Geometric Mean

95% Confidence Interval

ng/mL

Baseline, Week 4 and Week 8

ID	Title	Description
OG000	Baseline	After once daily administration of amlodipine 5 mg for 8 weeks in the screening period
OG001	Week 4
OG002	Week 8

Units	Counts
Participants	OG000

Secondary

Trough Plasma Concentrations of Amlodipine -Amlodipine 10 mg

Posted

Geometric Mean

95% Confidence Interval

ng/mL

Baseline, Week 4, and Week 8

ID	Title	Description
OG000	Baseline	After once daily administration of amlodipine 5 mg for 8 weeks in the screening period
OG001	Week 4
OG002	Week 8

Units	Counts
Participants	OG000

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	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).	ANCOVA		<0.001		Mean Difference (Final Values)	-4.1				95	-5.7	-2.5					Superiority or Other (legacy)

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	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).	ANCOVA		<0.001		Mean Difference (Final Values)	-7.1				95	-9.1	-5.1					Superiority or Other (legacy)

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	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).	ANCOVA		<0.001		Mean Difference (Final Values)	-4.0				95	-5.4	-2.6					Superiority or Other (legacy)

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	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).	Regression, Logistic		0.002		Odds Ratio (OR)	2.33				95	1.36	3.99					Superiority or Other (legacy)

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	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).	Regression, Logistic		<0.001		Odds Ratio (OR)	4.46				95	2.28	8.74					Superiority or Other (legacy)

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	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).	Regression, Logistic		0.001		Odds Ratio (OR)	2.55				95	1.50	4.36					Superiority or Other (legacy)

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	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).	Regression, Logistic		<0.001		Odds Ratio (OR)	4.16				95	2.12	8.19					Superiority or Other (legacy)

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds