An International, Multicentre, Open Label Study To Assess The Effectiveness OfAmlodipine –Atorvastatin Combination In Subjects With Hypertension andDyslipidaemia. (The JEWEL II Study) - JEWEL II

• Conditions: Concurrent hypertension (ICD code 80011/MedDRA: coded under preferred term vascular system order, code 10020772) and dyslipidaemia (ICD code 89212/MedDRA: coded under preferred term metabolism and nutrition disorder, code 10058108).

• Registration Number: EUCTR2004-000354-22-AT
• Lead Sponsor: Pfizer Corporation Austria GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09-24
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

• Treated or untreated subjects diagnosed with concurrent hypertension
and dyslipidaemia, qualifying for drug treatment according to the
governing guidelines.
• The BP level to be used for eligibility assessment will be the average of
the levels obtained at the qualifying visits. Blood pressure must be not
at target as defined by governing guidelines.
• The LDL-C level to be used for eligibility assessment is a single value
obtained at screening. LDL-C may be at target on medication or not at
target with or without medication as defined by governing guidelines.
• For subjects receiving dyslipidaemia and/or antihypertensive therapy at
screening, the doses of medication must be stable for at least 6 weeks
prior to baseline assessments.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Subjects whose BP is adequately maintained at target with or without
medication;
• Subjects who are currently treated with both amlodipine and
atorvastatin;
• Subjects who are being treated with amlodipine 10 mg or other maximum dose calcium channel blockade therapy, or have a serum LDL-C concentration =
2.5mmol/L(100 mg/dL) while being treated with atorvastatin 80 mg.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified