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

NCT00530946

Last updated date
Study Location
Pfizer Investigational Site
Fukuoka-shi, Fukuoka-ken, , Japan
Contact
1-800-718-1021

FOR MORE INFORMATION

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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 <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
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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Hypercholesterolemia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2009)
165
Original Enrollment  ICMJE
 (submitted: September 14, 2007)
160
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00530946
Other Study ID Numbers  ICMJE A3841058
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP