Study of Pitavastatin in Elderly Patients With Primary Hy... | NCT00330876

NCT00330876

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	Description	Intervention Names
Pitavastatin 2 mg QD	Experimental	Pitavastatin 2 mg once daily	Drug: Pitavastatin
Pitavastatin 4 mg QD	Experimental	Pitavastatin 4 mg once daily	Drug: Pitavastatin

Name	Type	Description	Arm Group Labels	Other Names
Pitavastatin	Drug		Pitavastatin 2 mg QD Pitavastatin 4 mg QD

Outcomes Module

Measure	Description	Time Frame
Change From Baseline in LDL-C	percent change from baseline in low density lipoprotein-cholesterol (LDL-C)	Baseline to 60 weeks

Measure	Description	Time Frame
Change From Baseline in Total Cholesterol	Percent change from baseline in total cholesterol (TC)	Baseline to 60 weeks

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Dragos Budinski, MD	Medical Director	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Copenhagen University Hospital		Copenhagen			Denmark
Medical Center

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

ID	Title	Description
FG000	Pitavastatin 2 mg QD	Pitavastatin 2 mg once daily
FG001	Pitavastatin 4 mg QD	Pitavastatin 4 mg once daily

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

Type of Units Analyzed

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000
Between 18 and 65 years	BG0000
>=65 years	BG000

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00070.3± 4.73

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000294
Male	BG000245

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 From Baseline in LDL-C

percent change from baseline in low density lipoprotein-cholesterol (LDL-C)

Subjects with measurement at Week 60

Posted

Aug 2009

Mean

Standard Deviation

percent change

Baseline to 60 weeks

ID	Title	Description
OG000	Pitavastatin 2 mg QD	Pitavastatin 2 mg once daily
OG001	Pitavastatin 4 mg QD	Pitavastatin 4 mg once daily

Units	Counts
Participants	OG000376 OG00177

Title

Denominators

Categories

Title	Measurements
	OG000-43.18± 10.065 OG001-44.26± 10.764

Secondary

Change From Baseline in Total Cholesterol

Percent change from baseline in total cholesterol (TC)

Subjects with a measurement at Week 60

Posted

Aug 2009

Mean

Standard Deviation

percent change

Baseline to 60 weeks

ID	Title	Description
OG000	Pitavastatin 2 mg QD	Pitavastatin 2 mg once daily
OG001	Pitavastatin 4 mg QD	Pitavastatin 4 mg once daily

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	Pitavastatin 2 mg QD	Pitavastatin 2 mg once daily			51	449	286
EG001	Pitavastatin 4 mg QD	Pitavastatin 4 mg once daily			7	90	24

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Acute mycocardial infarction	Cardiac disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Angina pectoris	Cardiac disorders	MedDRA 8.1	Non-systematic Assessment	EG0002 affected449 at risk EG0010 affected90 at risk
Aortic valve disease	Cardiac disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 8.1	Non-systematic Assessment	EG0000 affected449 at risk EG0011 affected90 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Atrioventricular block	Cardiac disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Cardiac arrest	Cardiac disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Cardiac failure	Cardiac disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Cporonary artery occlusion	Cardiac disorders	MedDRA 8.1	Non-systematic Assessment	EG0000 affected449 at risk EG0011 affected90 at risk
Myocardial infarction	Cardiac disorders	MedDRA 8.1	Non-systematic Assessment	EG0002 affected449 at risk EG0010 affected90 at risk
hypoacusis	Ear and labyrinth disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Glaucoma	Eye disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Macular hole	Eye disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Retinal detachment	Eye disorders	MedDRA 8.1	Non-systematic Assessment	EG0000 affected449 at risk EG0011 affected90 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Nausea	Gastrointestinal disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Oesophageal haemorrhage	Gastrointestinal disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Vomiting	Gastrointestinal disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Bronchopneumonia	Infections and infestations	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Lobar pneumonia	Infections and infestations	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Pneumonia	Infections and infestations	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Sialoadenitis	Infections and infestations	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Urinary tract infection	Infections and infestations	MedDRA 8.1	Non-systematic Assessment	EG0000 affected449 at risk EG0011 affected90 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Non-systematic Assessment	EG0000 affected449 at risk EG0011 affected90 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Non-systematic Assessment	EG0004 affected449 at risk EG0010 affected90 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Benign pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Non-systematic Assessment	EG0002 affected449 at risk EG0010 affected90 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Non-hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Non-systematic Assessment	EG0006 affected449 at risk EG0010 affected90 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Amnesia	Nervous system disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0011 affected90 at risk
Loss of consciousness	Nervous system disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Nervousness	Psychiatric disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Urethral stricture	Renal and urinary disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Daiphragmatic hernia	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 affected449 at risk EG0010 affected90 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 8.1	Non-systematic Assessment	EG0000 affected449 at risk EG0011 affected90 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 8.1	Non-systematic Assessment	EG00071 affected539 at risk EG0012 affected95 at risk
Urinary tract infection	Infections and infestations	MedDRA 8.1	Non-systematic Assessment	EG00026 affected539 at risk EG0014 affected95 at risk
Cystitis	Infections and infestations	MedDRA 8.1	Non-systematic Assessment	EG00026 affected539 at risk EG0011 affected95 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Non-systematic Assessment	EG00044 affected539 at risk EG0014 affected95 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Non-systematic Assessment	EG00034 affected539 at risk EG0013 affected95 at risk
Osteaoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Non-systematic Assessment	EG00024 affected539 at risk EG0015 affected95 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Non-systematic Assessment	EG00026 affected539 at risk EG0011 affected95 at risk
Hypertension	Vascular disorders	MedDRA 8.1	Non-systematic Assessment	EG00035 affected539 at risk EG0014 affected95 at risk

ID	Term
D006937	Hypercholesterolemia
D050171	Dyslipidemias

ID	Term
C108475	pitavastatin

ID	Term
D006949	Hyperlipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases