Clinical trial NCT00530946: A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Hypercholesterolemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-09-18
Enrollment: 165
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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.

Primary outcomes:
measure: Change in Systolic Blood Pressure
timeFrame: 8 weeks
measure: Percent Change in Low Density Lipoprotein-Cholesterol
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in Systolic Blood Pressure From Baseline to Each Observation Point
timeFrame: 2 weeks, 4 weeks, and 8 weeks
measure: Change in Diastolic Blood Pressure From Baseline to Each Observation Point
timeFrame: 2 weeks, 4 weeks , and 8 weeks
measure: Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point
timeFrame: 2 weeks, 4 weeks , and 8 weeks
measure: Percent Change in Total Cholesterol From Baseline to Each Observation Point
timeFrame: 2 weeks, 4 weeks , and 8 weeks
measure: Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point
timeFrame: 2 weeks, 4 weeks , and 8 weeks
measure: Percent Change in Triglycerides From Baseline to Each Observation Point
timeFrame: 2 weeks, 4 weeks , and 8 weeks
measure: Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point
timeFrame: 2 weeks, 4 weeks, and 8 weeks
measure: Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point
timeFrame: 2 weeks, 4 weeks , and 8 weeks
measure: Change in Apolipoprotein B From Baseline to Each Observation Point
timeFrame: 2 weeks, 4 weeks, and 8 weeks
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka-ken
city: Kitakyushu-shi
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka-ken
city: Kurume-shi
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka-ken
city: Maebaru-shi
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka-ken
city: Annaka
country: Japan
facility: Pfizer Investigational Site
state: Gunma
city: Sapporo-shi
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Teine
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Yokohama-shi
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa-ken
city: Yamashita-cho
country: Japan
facility: Pfizer Investigational Site
state: Naka-ku, Kanagawa-ken
city: Kita-ku
country: Japan
facility: Pfizer Investigational Site
state: Osaka-fu
city: Koshigaya-shi
country: Japan
facility: Pfizer Investigational Site
state: Saitama-ken
city: Chofu
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Kiyose
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinagawa-Ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinagawa
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Osaka
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: