Open Label Study To Evaluate The Long-Term Safety Profile... | NCT01190007

NCT01190007

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

Label	Type	Description	Intervention Names
Caduet	Experimental		Drug: Caduet

Name	Type	Description	Arm Group Labels	Other Names
Caduet	Drug	One Caduet tablet will be administered once daily after breakfast, in principle, for 52 weeks	Caduet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.	52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia	Value at each visits minus value at baseline	Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia

Eligibility Module

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Healthcare Corporation MEDOC Medical Dock&Clinic		Nagoya	Aichi-ken		Japan
Beppu Medical Clinic

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	Caduet	Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.

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

FG000159 subjectsTreated

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Caduet	Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG000120

SAE

Title	Measurements
	OG00011

Secondary

Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia

Value at each visits minus value at baseline

Posted

Mean

Standard Deviation

mmHg

Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

ID	Title	Description
OG000	Caduet	Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia

Value at each visits minus value at baseline

The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. Participants both angina pectoris and hypercholesterolemia were included the participants with all of angina pectoris, hypertension and hypercholesterolemia.

Posted

Mean

Standard Deviation

mmHg

Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

ID	Title	Description
OG000	Caduet	Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.

Units	Counts
Participants

Secondary

Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia

Value at each visits minus value at baseline

Posted

Mean

Standard Deviation

mmHg

Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

ID	Title	Description
OG000	Caduet	Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia

Value at each visits minus value at baseline

The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment.

Participants with both angina pectoris and hypercholesterolemia were included the participants with all of angina pectoris, hypertension and hypercholesterolemia.

Posted

Mean

Standard Deviation

mmHg

Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

ID	Title	Description
OG000	Caduet	Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.

Units	Counts
Participants

Secondary

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit

"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100

Posted

Mean

Standard Deviation

Percentage of LDL-C

Weeks 4, 12, 24, and 52

ID	Title	Description
OG000	Caduet	Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Total Cholesterol (TC) at Each Visit

"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100

Posted

Mean

Standard Deviation

Percentage of TC

Weeks 4, 12, 24, and 52

ID	Title	Description
OG000	Caduet	Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit

"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100

Posted

Mean

Standard Deviation

Percentage of HDL-C

Weeks 4, 12, 24, and 52

ID	Title	Description
OG000	Caduet	Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Triglyceride (TG) at Each Visit

"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100

Posted

Mean

Standard Deviation

Percentage of TG

Week 4, 12, 24, and 52

ID	Title	Description
OG000	Caduet	Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit

Value at each visits minus value at baseline

Posted

Mean

Standard Deviation

Ratio

Weeks 4, 12, 24, and 52

ID	Title	Description
OG000	Caduet	Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit

Value at each visits minus value at baseline

Posted

Mean

Standard Deviation

Ratio

Weeks 4, 12, 24, and 52

ID	Title	Description
OG000	Caduet	Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Apolipoprotein B at Each Visit

"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100

Posted

Mean

Standard Deviation

Percentage of Apolipoprotein B

Week 4, 12, 24, and 52

ID	Title	Description
OG000	Caduet	Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Caduet	Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.			11	159	101	159

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected159 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected159 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected159 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected159 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected159 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected159 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected159 at risk
Benign soft tissue neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected159 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected159 at risk
Carcinoid tumour of the gastrointestinal tract	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected159 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected159 at risk
Rectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected159 at risk
Aortic aneurysm	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected159 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal discomfort	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected159 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected159 at risk
Gastritis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected159 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected159 at risk
Bronchitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00011 affected159 at risk
Cystitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0006 affected159 at risk
Nasopharyngitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00053 affected159 at risk
Pharyngitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00017 affected159 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0009 affected159 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected159 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected159 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected159 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected159 at risk
Headache	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected159 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected159 at risk
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected159 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0009 affected159 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected159 at risk

ID	Term
D006973	Hypertension
D006937	Hypercholesterolemia
D000787	Angina Pectoris

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
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002637	Chest Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C487936	amlodipine, atorvastatin drug combination