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A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Fukuoka-shi, Fukuoka-ken, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension, Hypercholesterolemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-79 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- The out-patient with concurrent hypertension and hyper-LDL-cholesterolemia is a male
or female >=20 to

- The SBP at Visit 4 (Week -1) and Visit 5 (Week 0) is continuously SBP >=140 mmHg and

- LDL-C >=140 mg/dL and

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00530946
Pfizer
Completed
A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin

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A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin
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
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hypertension
  • Hypercholesterolemia
  • Drug: Amlodipine 2.5mg/Atorvastatin 5mg
    Single pill combination, dosed once daily for 8 weeks
  • Drug: Amlodipine 2.5mg/Atorvastatin 10mg
    Single pill combination, dosed once daily for 8 weeks
  • Drug: Amlodipine 5mg/Atorvastatin 5mg
    Single pill combination, dosed once daily for 8 weeks
  • Drug: Amlodipine 5mg/Atorvastatin 10mg
    Single pill combination, dosed once daily for 8 weeks
  • Active Comparator: CI-1038 2.5mg/5mg
    Intervention: Drug: Amlodipine 2.5mg/Atorvastatin 5mg
  • Active Comparator: CI-1038 2.5mg/10mg
    Intervention: Drug: Amlodipine 2.5mg/Atorvastatin 10mg
  • Active Comparator: CI-1038 5mg/5mg
    Intervention: Drug: Amlodipine 5mg/Atorvastatin 5mg
  • Active Comparator: CI-1038 5mg/10mg
    Intervention: Drug: Amlodipine 5mg/Atorvastatin 10mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
165
April 2008
April 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 79 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00530946
A3841058
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

BY EMAIL

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[email protected]



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