Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

• Sponsor: Kowa Research Europe (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00330876
• Collaborator: (none)
• Enrollment: 545
• Locations: 59
• Arms: 2
• Duration (Months): 18
• Patients Per Site: 9.2
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This is an open-label extension study of NK-104-306 (NCT00257686) for elderly patients with hypercholesterolemia or combined dyslipidemia.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia; Dyslipidemias	Drug: Pitavastatin	Phase 3

Detailed Description

This was an open-label study of 60 weeks duration in elderly patients (≥65 years) with primary hypercholesterolemia or combined dyslipidemia who completed the 12 week treatment in study NK-104-306 and who met the inclusion/exclusion criteria. Patients who qualified started open-label treatment with pitavastatin 2 mg QD. The dose of pitavastatin could be increased to 4 mg QD after at least 8 weeks of treatment at 2 mg QD, in patients who failed to attain their LDL-C target.

Study Design

• Study Type: Interventional
• Actual Enrollment: 545 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-Label, Long-Term (> 1 Year) Extension Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pitavastatin 2 mg QD Pitavastatin 2 mg once daily	Drug: Pitavastatin
Experimental: Pitavastatin 4 mg QD Pitavastatin 4 mg once daily	Drug: Pitavastatin

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in LDL-C [Baseline to 60 weeks]

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

Secondary Outcome Measures

1. Change From Baseline in Total Cholesterol [Baseline to 60 weeks]

   Percent change from baseline in total cholesterol (TC)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Greater than or equal to 65 years of age

• Primary hypercholesterolemia

• Combined dyslipidemia

• Completed study NK-104-306 (NCT00257686)

Exclusion Criteria:

• Failed to complete study NK-104-306(NCT00257686)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Copenhagen University Hospital	Copenhagen		Denmark
2	Medical Center	Copenhagen		Denmark
3	CCBR A/S	Vejle		Denmark
4	Kardiologische Gemeinschaftspraxis Prof. Reifart	Bad Soden/Taunus		Germany
5	Praxis Dr. Boenninghoff	Beckum		Germany
6	Klinische Forschung Berlin Mitte	Berlin		Germany
7	GWT-TUK GmbH, Zentrum fur Klinische Studien	Dresden		Germany
8	Gemeinschaftspraxis Dr. Krause, Th. Menke	Goch		Germany
9	Klinische Forschung Hamburg	Hamburg		Germany
10	Innere Medizin I/Medizinische Klinik	Heidelberg		Germany
11	Gemeinschaftspraxis H. Holz Dr. Med, K. W. Klingl	Lampertheim		Germany
12	ZET-Studien GmbH Leipzig	Leipzig		Germany
13	Internistische Gemeinschaftspraxis	Mainz		Germany
14	Praxis Dr. Wachter	Mannheim		Germany
15	Gemeinschaftspraxis Melcherstaette	Melcherstaette		Germany
16	Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler	Messkirch		Germany
17	Praxisgemeinschaft im Kleinen Biergrund	Offenbach/M		Germany
18	Gemeinschaftspraxis Drs. Mockesch	Weinheim		Germany
19	Intermed Institud Fur Klinische Forschung und Arzn	Wiesbaden		Germany
20	Gemeinschaftspraxis Dr. Emden, Frank Drewes	Worpswede		Germany
21	Department of Internal Medicine, Soroka Medical Center	Beersheva		Israel
22	Department of Internal Medicine A, Rambal Medical Center	Haifa		Israel
23	Department of Internal Medicine, Wolfson Medical Center	Holon		Israel
24	Center for Research, Hadassah University Hospital	Jerusalem Ein Kerem		Israel
25	Meir Hospital	Kfar Saba		Israel
26	Department of Medicine, Hadassah Medical Center	Mount Scopus Jerusalem		Israel
27	Department of Internal Medicine, Rivka Sieff Medical Center	Safed		Israel
28	Institute of Metabolic Diseases	Tel Aviv		Israel
29	Institute of Lipid & Atherosclerosis Research	Tel Hashomer		Israel
30	Andromed Breda	Breda		Netherlands
31	Andromed Noord	Groningen		Netherlands
32	Vasculair Onderzoek Centrum Hoorn	Hoorn		Netherlands
33	Andromed Leiden	Leiden		Netherlands
34	Andromed Nijmegen	Nijmegen		Netherlands
35	Andromed Rotterdam	Rotterdam		Netherlands
36	Albert Schweitzer Ziekenhuis	Sliedrecht		Netherlands
37	Rivierenland Tiel	Tiel		Netherlands
38	Andromed Oost	Velp		Netherlands
39	Andromed Zoetermeer	Zoetermeer		Netherlands
40	Oldfield Surgery	Bath		United Kingdom
41	St James's Surgery	Bath		United Kingdom
42	The Pulteney Practice	Bath		United Kingdom
43	Birmingham Clinical Research Centre	Birmingham		United Kingdom
44	Stonehill Medical Center	Bolton		United Kingdom
45	Chorley Clinical Research Centre	Chorley		United Kingdom
46	Saltash Health Center	Cornwall		United Kingdom
47	Gomersal Lane Surgery	Dronfield		United Kingdom
48	Townhead Research	Irvine		United Kingdom
49	Crosby Clinical Research Centre	Liverpool		United Kingdom
50	The Symons Medical Center	Maidenhead		United Kingdom
51	Manchester Clinical Research Centre	Manchester		United Kingdom
52	Greenwood Medical Center	Nottingham		United Kingdom
53	Reading Clinical Research Centre	Reading		United Kingdom
54	Elm Lane Surgery	Sheffield		United Kingdom
55	Brook Lane Surgery	Southampton		United Kingdom
56	Bradford Road Medical Center	Wiltshire		United Kingdom
57	Rowden Medical Partnership	Wiltshire		United Kingdom
58	The Porch Surgery	Wiltshire		United Kingdom
59	The Burns Medical Practice	Yorkshire		United Kingdom

Sponsors and Collaborators

• Kowa Research Europe

Investigators

• Study Director: Dragos Budinski, MD, Medical Director

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00330876
• Other Study ID Numbers: NK-104-308EU
• First Posted: May 29, 2006
• Last Update Posted: Mar 16, 2010
• Last Verified: Mar 1, 2010

• Keywords provided by , ,: pitavastatin; hypercholesterolemia; combined dyslipidemia
• Additional relevant MeSH terms: Hypercholesterolemia; Dyslipidemias; Pitavastatin

Study Results

Participant Flow

Arm/Group Title	Pitavastatin 2 mg QD	Pitavastatin 4 mg QD
Arm/Group Description	Pitavastatin 2 mg once daily	Pitavastatin 4 mg once daily
Period Title: Overall Study
STARTED	449	90
COMPLETED	378	77
NOT COMPLETED	71	13

Baseline Characteristics

Arm/Group Title	Safety Population
Arm/Group Description	Subjects who received at least one dose of Pitavastatin 2 or 4 mg once daily
Overall Participants	539
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	0 0%
>=65 years	539 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.3 (4.73)
Sex: Female, Male (Count of Participants)
Female	294 54.5%
Male	245 45.5%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects with measurement at Week 60

Arm/Group Title	Pitavastatin 2 mg QD	Pitavastatin 4 mg QD
Arm/Group Description	Pitavastatin 2 mg once daily	Pitavastatin 4 mg once daily
Measure Participants	376	77
Mean (Standard Deviation) [percent change]	-43.18 (10.065)	-44.26 (10.764)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects with a measurement at Week 60

Arm/Group Title	Pitavastatin 2 mg QD	Pitavastatin 4 mg QD
Arm/Group Description	Pitavastatin 2 mg once daily	Pitavastatin 4 mg once daily
Measure Participants	378	77
Mean (Standard Deviation) [percent change]	-28.27 (8.214)	-30.54 (8.226)

Adverse Events

Arm/Group Title	Pitavastatin 2 mg QD		Pitavastatin 4 mg QD
Arm/Group Description	Pitavastatin 2 mg once daily		Pitavastatin 4 mg once daily
All Cause Mortality
	Pitavastatin 2 mg QD		Pitavastatin 4 mg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pitavastatin 2 mg QD		Pitavastatin 4 mg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	51/449 (11.4%)		7/90 (7.8%)
Cardiac disorders
Acute coronary syndrome	1/449 (0.2%)		0/90 (0%)
Acute mycocardial infarction	1/449 (0.2%)		0/90 (0%)
Angina pectoris	2/449 (0.4%)		0/90 (0%)
Aortic valve disease	1/449 (0.2%)		0/90 (0%)
Aortic valve incompetence	0/449 (0%)		1/90 (1.1%)
Atrial fibrillation	1/449 (0.2%)		0/90 (0%)
Atrioventricular block	1/449 (0.2%)		0/90 (0%)
Cardiac arrest	1/449 (0.2%)		0/90 (0%)
Cardiac failure	1/449 (0.2%)		0/90 (0%)
Cporonary artery occlusion	0/449 (0%)		1/90 (1.1%)
Myocardial infarction	2/449 (0.4%)		0/90 (0%)
Ear and labyrinth disorders
hypoacusis	1/449 (0.2%)		0/90 (0%)
Eye disorders
Glaucoma	1/449 (0.2%)		0/90 (0%)
Macular hole	1/449 (0.2%)		0/90 (0%)
Retinal detachment	0/449 (0%)		1/90 (1.1%)
Gastrointestinal disorders
Abdominal pain upper	1/449 (0.2%)		0/90 (0%)
Inguinal hernia	1/449 (0.2%)		0/90 (0%)
Intestinal obstruction	1/449 (0.2%)		0/90 (0%)
Nausea	1/449 (0.2%)		0/90 (0%)
Oesophageal haemorrhage	1/449 (0.2%)		0/90 (0%)
Vomiting	1/449 (0.2%)		0/90 (0%)
Infections and infestations
Bronchopneumonia	1/449 (0.2%)		0/90 (0%)
Lobar pneumonia	1/449 (0.2%)		0/90 (0%)
Pneumonia	1/449 (0.2%)		0/90 (0%)
Sialoadenitis	1/449 (0.2%)		0/90 (0%)
Urinary tract infection	0/449 (0%)		1/90 (1.1%)
Injury, poisoning and procedural complications
Ankle fracture	1/449 (0.2%)		0/90 (0%)
Femoral neck fracture	0/449 (0%)		1/90 (1.1%)
Joint dislocation	1/449 (0.2%)		0/90 (0%)
Tendon rupture	1/449 (0.2%)		0/90 (0%)
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	1/449 (0.2%)		0/90 (0%)
Muscle spasms	1/449 (0.2%)		0/90 (0%)
Osteoarthritis	4/449 (0.9%)		0/90 (0%)
Osteonecrosis	1/449 (0.2%)		0/90 (0%)
Periarthritis	1/449 (0.2%)		0/90 (0%)
Rotator cuff syndrome	1/449 (0.2%)		0/90 (0%)
Spinal osteoarthritis	1/449 (0.2%)		0/90 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign pancreatic neoplasm	1/449 (0.2%)		0/90 (0%)
Bladder neoplasm	1/449 (0.2%)		0/90 (0%)
Brain neoplasm	1/449 (0.2%)		0/90 (0%)
Breast cancer	2/449 (0.4%)		0/90 (0%)
Colon cancer	1/449 (0.2%)		0/90 (0%)
Lung neoplasm malignant	1/449 (0.2%)		0/90 (0%)
Malignant melanoma	1/449 (0.2%)		0/90 (0%)
Metastases to central nervous system	1/449 (0.2%)		0/90 (0%)
Non-hodgkin's lymphoma	1/449 (0.2%)		0/90 (0%)
Prostate cancer	6/449 (1.3%)		0/90 (0%)
Uterine cancer	1/449 (0.2%)		0/90 (0%)
Nervous system disorders
Amnesia	1/449 (0.2%)		0/90 (0%)
Cerebrovascular accident	1/449 (0.2%)		1/90 (1.1%)
Loss of consciousness	1/449 (0.2%)		0/90 (0%)
Psychiatric disorders
Nervousness	1/449 (0.2%)		0/90 (0%)
Renal and urinary disorders
Bladder prolapse	1/449 (0.2%)		0/90 (0%)
Urethral stricture	1/449 (0.2%)		0/90 (0%)
Respiratory, thoracic and mediastinal disorders
Daiphragmatic hernia	1/449 (0.2%)		0/90 (0%)
Pulmonary embolism	1/449 (0.2%)		0/90 (0%)
Vascular disorders
Deep vein thrombosis	1/449 (0.2%)		0/90 (0%)
Peripheral vascular disorder	0/449 (0%)		1/90 (1.1%)
Other (Not Including Serious) Adverse Events
	Pitavastatin 2 mg QD		Pitavastatin 4 mg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	286/ (NaN)		24/ (NaN)
Infections and infestations
Nasopharyngitis	71/539 (13.2%)		2/95 (2.1%)
Urinary tract infection	26/539 (4.8%)		4/95 (4.2%)
Cystitis	26/539 (4.8%)		1/95 (1.1%)
Musculoskeletal and connective tissue disorders
Myalgia	44/539 (8.2%)		4/95 (4.2%)
Arthralgia	34/539 (6.3%)		3/95 (3.2%)
Osteaoarthritis	24/539 (4.5%)		5/95 (5.3%)
Respiratory, thoracic and mediastinal disorders
Cough	26/539 (4.8%)		1/95 (1.1%)
Vascular disorders
Hypertension	35/539 (6.5%)		4/95 (4.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.