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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

Page last updated: June 20, 2008

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