A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin
Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Hypercholesterolemia
Intervention: Amlodipine 2.5mg/Atorvastatin 5mg (Drug); Amlodipine 2.5mg/Atorvastatin 10mg (Drug); Amlodipine 5mg/Atorvastatin 5mg (Drug); Amlodipine 5mg/Atorvastatin 10mg (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in
Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in Systolic Blood PressurePercent Change in Low Density Lipoprotein-Cholesterol
Secondary outcome: Change in Systolic Blood Pressure From Baseline to Each Observation PointChange in Diastolic Blood Pressure From Baseline to Each Observation Point Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point Percent Change in Total Cholesterol From Baseline to Each Observation Point Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point Percent Change in Triglycerides From Baseline to Each Observation Point Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point Change in Apolipoprotein B From Baseline to Each Observation Point
Eligibility
Minimum age: 20 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- The out-patient with concurrent hypertension and hyper-LDL-cholesterolemia is a male
or female >=20 to <80 years of age at Visit 1.
- The SBP at Visit 4 (Week -1) and Visit 5 (Week 0) is continuously SBP >=140 mmHg and
<180 mmHg,
- LDL-C >=140 mg/dL and <250 mg/dL at Visit 3 (Week -2) and 4 (Week -1).
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.
Locations and Contacts
Pfizer Investigational Site, Osaka, Japan
Pfizer Investigational Site, Fukuoka-shi, Fukuoka-ken, Japan
Pfizer Investigational Site, Kitakyushu-shi, Fukuoka-ken, Japan
Pfizer Investigational Site, Kurume-shi, Fukuoka-ken, Japan
Pfizer Investigational Site, Maebaru-shi, Fukuoka-ken, Japan
Pfizer Investigational Site, Annaka, Gunma, Japan
Pfizer Investigational Site, Sapporo-shi, Hokkaido, Japan
Pfizer Investigational Site, Teine, Hokkaido, Japan
Pfizer Investigational Site, Yokohama-shi, Kanagawa-ken, Japan
Pfizer Investigational Site, Yamashita-cho, Naka-ku, Kanagawa-ken, Japan
Pfizer Investigational Site, Kita-ku, Osaka-fu, Japan
Pfizer Investigational Site, Koshigaya-shi, Saitama-ken, Japan
Pfizer Investigational Site, Chofu, Tokyo, Japan
Pfizer Investigational Site, Kiyose, Tokyo, Japan
Pfizer Investigational Site, Setagaya-ku, Tokyo, Japan
Pfizer Investigational Site, Shinagawa-Ku, Tokyo, Japan
Pfizer Investigational Site, Shinagawa, Tokyo, Japan
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: September 2007
Last updated: April 28, 2009
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