A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00530946

Purpose

To assess the changes in the trough Systolic Blood Pressure (SBP) and the % changes in LDL-C from baseline at Week 8 in the treatment period

Condition	Intervention	Phase
Hypertension Hypercholesterolemia	Drug: CI-1038 (Caduet） Drug: CI-1038(Caduet) Drug: CI-1038 (Caduet)	Phase III

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol High Blood Pressure

Drug Information available for: Atorvastatin Atorvastatin calcium Amlodipine Amlodipine besylate Caduet

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin In The Treatment Of Concurrent Hypertension And Hyper-LDL-Cholesterolemia

Further study details as provided by Pfizer:

Primary Outcome Measures:

The change in SBP and the percent change in LDL-C from baseline at Week 8 in the treatment period. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

1.The changes in the following efficacy endpoints from baseline to each visit: SBP (except that at Week 8), DBP, LDL-C (except that at Week 8), TC, HDL-C, TG, LDL-C/HDL-C ratio, TC/HDL-C ratio and ApolipoproteinB. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
2. Safety endpoints (Adverse events, laboratory tests, 12-lead ECG, pulse rate) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	160
Study Start Date:	September 2007
Study Completion Date:	April 2008

Arms	Assigned Interventions
2.5/5: Active Comparator Amlodipine 2.5mg/Atorvastation 5mg	Drug: CI-1038 (Caduet) Amlodipine/Atorvastatin
2.5/10: Active Comparator Amlodipine 2.5mg/Atorvastation 10mg	Drug: CI-1038 (Caduet） Amlodipine/atorvastatin single pill combination dosed at 2.5 mg / 10 mg. Dosed once daily for 8 weeks
5/10: Active Comparator Amlodipine 5mg/Atorvastatin 10mg	Drug: CI-1038(Caduet) Amlodipine/Atorvastatin
5/5: Active Comparator Amlodipine 5mg/Atorvastation 5mg	Drug: CI-1038 (Caduet） Amlodipine/Atorvastatin

Eligibility

Ages Eligible for Study:	20 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The out-patient with concurrent hypertension and hypercholesterolemia is a male or female >=20 to <80 years of age at Visit 1.
The SBP at Visit 4 and Visit 5 is continuously SBP >=140 mmHg and <180 mmHg,
LDL-C >=140 mg/dL and <250 mg/dL at Visit 3 and 4.

Exclusion Criteria:

Subjects who had experienced the following coronary artery disease within the past 3 months.
Myocardial infarction
Receiving PCI（percutaneous coronary intervention）or CABG (coronary artery bypass grafting)
Any clinically meaningful valvular disease
Subjects with a history of cerebrovascular diseases such as stroke or transient ischemic attack within the past 3 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530946

Locations

Japan
Pfizer Investigational Site
Osaka, Japan
Japan, Fukuoka-ken
Pfizer Investigational Site
Kitakyushu-shi, Fukuoka-ken, Japan
Pfizer Investigational Site
Fukuoka-shi, Fukuoka-ken, Japan
Pfizer Investigational Site
Maebaru-shi, Fukuoka-ken, Japan
Pfizer Investigational Site
Kurume-shi, Fukuoka-ken, Japan
Japan, Gunma
Pfizer Investigational Site
Annaka, Gunma, Japan
Japan, Hokkaido
Pfizer Investigational Site
Teine, Hokkaido, Japan
Pfizer Investigational Site
Sapporo-shi, Hokkaido, Japan
Japan, Kanagawa-ken
Pfizer Investigational Site
Yokohama-shi, Kanagawa-ken, Japan
Japan, Naka-ku, Kanagawa-ken
Pfizer Investigational Site
Yamashita-cho, Naka-ku, Kanagawa-ken, Japan
Japan, Osaka-fu
Pfizer Investigational Site
Kita-ku, Osaka-fu, Japan
Japan, Saitama-ken
Pfizer Investigational Site
Koshigaya-shi, Saitama-ken, Japan
Japan, Tokyo
Pfizer Investigational Site
Shinagawa-Ku, Tokyo, Japan
Pfizer Investigational Site
Setagaya-ku, Tokyo, Japan
Pfizer Investigational Site
Shinagawa, Tokyo, Japan
Pfizer Investigational Site
Chofu, Tokyo, Japan
Pfizer Investigational Site
Kiyose, Tokyo, Japan

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3841058
Study First Received:	September 13, 2007
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00530946
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Calcium, Dietary
Metabolic Diseases
Hyperlipidemias
Vascular Diseases
Hyperkinesis
Metabolic disorder

Hypercholesterolemia
Atorvastatin
Dyslipidemias
Amlodipine
Lipid Metabolism Disorders
Hypertension

Additional relevant MeSH terms:

Antimetabolites
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents

Anticholesteremic Agents
Antihypertensive Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Membrane Transport Modulators
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009