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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00330785
First received: February 28, 2006
Last updated: January 6, 2010
Last verified: April 2007
  Purpose

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 Intervention Phase
Hypertension
Dyslipidemia
Drug: Amlodipine/Atorvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

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

Estimated Enrollment: 1250
Study Start Date: October 2004
Estimated Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330785

  Show 126 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00330785     History of Changes
Other Study ID Numbers: A3841018
Study First Received: February 28, 2006
Last Updated: January 6, 2010
Health Authority: United Kingdom: Department of Health

Additional relevant MeSH terms:
Dyslipidemias
Hypertension
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Amlodipine
Amlodipine, atorvastatin drug combination
Atorvastatin
Anticholesteremic Agents
Antihypertensive Agents
Antimetabolites
Calcium Channel Blockers
Cardiovascular Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 22, 2014