A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Hypercholesterolemia
Intervention: CI-1038 (Caduet） (Drug); CI-1038 (Caduet） (Drug); CI-1038(Caduet) (Drug); CI-1038 (Caduet) (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 % changes in 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: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The change in SBP and the percent change in LDL-C from baseline at Week 8 in the treatment period.
Secondary outcome: 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.2. Safety endpoints (Adverse events, laboratory tests, 12-lead ECG, pulse rate)
Eligibility
Minimum age: 20 Years.
Maximum age: 79 Years.
Gender(s): Both.
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.
Locations and Contacts
Pfizer Investigational Site, Osaka, Japan
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
Pfizer Investigational Site, Annaka, Gunma, Japan
Pfizer Investigational Site, Teine, Hokkaido, Japan
Pfizer Investigational Site, Sapporo-shi, 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, Shinagawa-Ku, Tokyo, Japan
Pfizer Investigational Site, Kiyose, Tokyo, Japan
Pfizer Investigational Site, Shinagawa, Tokyo, Japan
Pfizer Investigational Site, Chofu, Tokyo, Japan
Pfizer Investigational Site, Setagaya-ku, Tokyo, Japan
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: September 2007
Ending date: April 2008
Last updated: April 14, 2008
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