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Open Label Study Assessing Effectiveness Of Amlodipine/Atorvastatin In Subjects With Hypertension and Dyslipidaemia (JEWEL I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00330785
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : January 8, 2010
Sponsor:
Information provided by:
Pfizer

Study Description
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Brief Summary:
To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing the percentage of subjects who reach target blood pressure (BP) and LDL-C targets as defined by their governing guidelines.

Condition or disease Intervention/treatment Phase
Hypertension Dyslipidemia Drug: Amlodipine/Atorvastatin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 1250 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An International, Multicentre, Open Label Study To Assess The Effectiveness Of Amlodipine -Atorvastatin Combination In Subjects With Hypertension and Dyslipidaemia. (The JEWEL Study)
Study Start Date : October 2004
Study Completion Date : September 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the number of patients who reach target blood pressure (BP) and
  2. LDL-C targets as defined by their governing guidelines.

Secondary Outcome Measures :
  1. To assess changes from baseline to end of treatment for the following efficacy
  2. parameters: LDL-C, total cholesterol (TC), triglycerides, high-density lipoprotein
  3. cholesterol (HDL-C), HDL-C/LDL-C ratio, TC/HDL-C ratio. Systolic Blood Pressure
  4. (SBP) and Diastolic Blood Pressue (DBP).

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are above target LDL-C and BP who are eligible for treatment

Exclusion Criteria:

  • High liver enzymes
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330785


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00330785    
Other Study ID Numbers: A3841018
First Posted: May 29, 2006    Key Record Dates
Last Update Posted: January 8, 2010
Last Verified: April 2007
Additional relevant MeSH terms:
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Hypertension
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Amlodipine
Amlodipine, atorvastatin drug combination
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents