A Randomized Study To Evaluate Efficacy And Safety Of A F... | NCT00530946

NCT00530946

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
CI-1038 2.5mg/5mg	Active Comparator	Drug: Amlodipine 2.5mg/Atorvastatin 5mg
CI-1038 2.5mg/10mg	Active Comparator	Drug: Amlodipine 2.5mg/Atorvastatin 10mg
CI-1038 5mg/5mg	Active Comparator	Drug: Amlodipine 5mg/Atorvastatin 5mg
CI-1038 5mg/10mg	Active Comparator	Drug: Amlodipine 5mg/Atorvastatin 10mg

Name	Type	Description	Arm Group Labels	Other Names
Amlodipine 2.5mg/Atorvastatin 5mg	Drug	Single pill combination, dosed once daily for 8 weeks	CI-1038 2.5mg/5mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Systolic Blood Pressure	Value at Week 8 minus value at baseline	8 weeks
Percent Change in Low Density Lipoprotein-Cholesterol	Percent of "value at Week 8 minus value at baseline" over value at baseline	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in Systolic Blood Pressure From Baseline to Each Observation Point	Value at Week 2, Week 4, or Week 8 minus value at baseline	2 weeks, 4 weeks, and 8 weeks
Change in Diastolic Blood Pressure From Baseline to Each Observation Point

Eligibility Module

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Fukuoka	Fukuoka		Japan
Pfizer Investigational Site

References Module

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

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	CI-1038 2.5 mg/5 mg	Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
FG001	CI-1038 2.5 mg/10 mg	Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Value at Week 2, Week 4, or Week 8 minus value at baseline

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	CI-1038 2.5 mg/5 mg	Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
BG001	CI-1038 2.5 mg/10 mg	Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
BG002	CI-1038 5 mg/5 mg	Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
BG003	CI-1038 5 mg/10 mg	Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00043 BG00141 BG00241 BG00340 BG004165

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

participants

Title

Denominators

Categories

<20 years

Title	Measurements
	BG0000 BG0010 BG0020 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00023 BG00128 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Japan

Title	Measurements
	BG00043 BG00141 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

Value at Week 8 minus value at baseline

Full Analysis Set, Last Observation Carried Forward

Posted

Least Squares Mean

Standard Error

mm Hg

8 weeks

ID	Title	Description
OG000	CI-1038 2.5 mg/5 mg	Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
OG001	CI-1038 2.5 mg/10 mg	Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
OG002	CI-1038 5 mg/5 mg	Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
OG003	CI-1038 5 mg/10 mg	Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)

Units	Counts
Participants	OG00043 OG00141 OG00241 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-16.6± 1.65 OG001-15.9± 1.69 OG002-21.8± 1.69 OG003

Primary

Percent Change in Low Density Lipoprotein-Cholesterol

Percent of "value at Week 8 minus value at baseline" over value at baseline

Full Analysis Set, Last Observation Carried Forward

Posted

Least Squares Mean

Standard Error

Percent Change

8 weeks

ID	Title	Description
OG000	CI-1038 2.5 mg/5 mg	Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
OG001	CI-1038 2.5 mg/10 mg	Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
OG002	CI-1038 5 mg/5 mg	Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
OG003	CI-1038 5 mg/10 mg	Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)

Secondary

Change in Systolic Blood Pressure From Baseline to Each Observation Point

Value at Week 2, Week 4, or Week 8 minus value at baseline

Full Analysis Set, Observed Cases

Posted

Mean

Standard Deviation

mm Hg

2 weeks, 4 weeks, and 8 weeks

ID	Title	Description
OG000	CI-1038 2.5 mg/5 mg	Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
OG001	CI-1038 2.5 mg/10 mg	Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
OG002	CI-1038 5 mg/5 mg	Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
OG003	CI-1038 5 mg/10 mg	Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)

Secondary

Change in Diastolic Blood Pressure From Baseline to Each Observation Point

Value at Week 2, Week 4, or Week 8 minus value at baseline

Full Analysis Set, Observed Cases

Posted

Mean

Standard Deviation

mm Hg

2 weeks, 4 weeks , and 8 weeks

ID	Title	Description
OG000	CI-1038 2.5 mg/5 mg	Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
OG001	CI-1038 2.5 mg/10 mg	Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
OG002	CI-1038 5 mg/5 mg	Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
OG003	CI-1038 5 mg/10 mg	Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)

Secondary

Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point

Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline

Full Analysis Set, Observed Cases

Posted

Mean

Standard Deviation

Percent Change

2 weeks, 4 weeks , and 8 weeks

ID	Title	Description
OG000	CI-1038 2.5 mg/5 mg	Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
OG001	CI-1038 2.5 mg/10 mg	Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
OG002	CI-1038 5 mg/5 mg	Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
OG003	CI-1038 5 mg/10 mg	Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)

Secondary

Percent Change in Total Cholesterol From Baseline to Each Observation Point

Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline

Full Analysis Set, Observed Cases

Posted

Mean

Standard Deviation

Percent Change

2 weeks, 4 weeks , and 8 weeks

ID	Title	Description
OG000	CI-1038 2.5 mg/5 mg	Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
OG001	CI-1038 2.5 mg/10 mg	Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
OG002	CI-1038 5 mg/5 mg	Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
OG003	CI-1038 5 mg/10 mg	Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)

Secondary

Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point

Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline

Full Analysis Set, Observed Cases

Posted

Mean

Standard Deviation

Percent Change

2 weeks, 4 weeks , and 8 weeks

ID	Title	Description
OG000	CI-1038 2.5 mg/5 mg	Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
OG001	CI-1038 2.5 mg/10 mg	Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
OG002	CI-1038 5 mg/5 mg	Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
OG003	CI-1038 5 mg/10 mg	Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)

Secondary

Percent Change in Triglycerides From Baseline to Each Observation Point

Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline

Full Analysis Set, Observed Cases

Posted

Mean

Standard Deviation

Percent Change

2 weeks, 4 weeks , and 8 weeks

ID	Title	Description
OG000	CI-1038 2.5 mg/5 mg	Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
OG001	CI-1038 2.5 mg/10 mg	Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
OG002	CI-1038 5 mg/5 mg	Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
OG003	CI-1038 5 mg/10 mg	Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)

Secondary

Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point

Value at Week 2, Week 4, or Week 8 minus value at baseline

Full Analysis Set, Observed Cases

Posted

Mean

Standard Deviation

Ratio

2 weeks, 4 weeks, and 8 weeks

ID	Title	Description
OG000	CI-1038 2.5 mg/5 mg	Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
OG001	CI-1038 2.5 mg/10 mg	Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
OG002	CI-1038 5 mg/5 mg	Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
OG003	CI-1038 5 mg/10 mg	Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)

Secondary

Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point

Value at Week 2, Week 4, or Week 8 minus value at baseline

Full Analysis Set, Observed Cases

Posted

Mean

Standard Deviation

Ratio

2 weeks, 4 weeks , and 8 weeks

ID	Title	Description
OG000	CI-1038 2.5 mg/5 mg	Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
OG001	CI-1038 2.5 mg/10 mg	Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
OG002	CI-1038 5 mg/5 mg	Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
OG003	CI-1038 5 mg/10 mg	Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)

Secondary

Change in Apolipoprotein B From Baseline to Each Observation Point

Value at Week 2, Week 4, or Week 8 minus value at baseline

Full Analysis Set, Observed Cases

Posted

Mean

Standard Deviation

mg/dL

2 weeks, 4 weeks, and 8 weeks

ID	Title	Description
OG000	CI-1038 2.5 mg/5 mg	Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
OG001	CI-1038 2.5 mg/10 mg	Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
OG002	CI-1038 5 mg/5 mg	Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
OG003	CI-1038 5 mg/10 mg	Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)

Arm/Groups

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CI-1038 2.5 mg/5 mg	Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)	43	6	43
EG001	CI-1038 2.5 mg/10 mg	Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)	41	7	41
EG002	CI-1038 5 mg/5 mg	Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)	41	8	41
EG003	CI-1038 5 mg/10 mg	Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)	40	8	40

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected43 at risk EG0012 affected41 at risk EG0020 affected41 at risk EG0030 affected40 at risk
Seasonal Allergy	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected43 at risk EG0010 affected41 at risk EG0022 affected41 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0006 affected43 at risk EG0013 affected41 at risk EG0025 affected41 at risk EG003
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected43 at risk EG0012 affected41 at risk EG0021 affected41 at risk EG003
Headache	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected43 at risk EG0012 affected41 at risk EG0020 affected41 at risk EG003

ID	Term
D006973	Hypertension
D006937	Hypercholesterolemia

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D017311	Amlodipine
D000069059	Atorvastatin

Ancestor Terms

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011758	Pyrroles
D001393	Azoles
D006538	Heptanoic Acids
D005227	Fatty Acids
D008055	Lipids