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Amlodipine/Atorvastatin Combination to Reduce the Health Risk of High Blood Pressure and High Cholesterol Levels (GEMINI-AALA)

CLINICAL UTILITY OF AMLODIPINE / ATORVASTATIN TO IMPROVE THE CONDITIONAL CARDIOVASCULAR RISK FACTORS OF HYPERTENSION AND DISLIPIDEMIA (GEMINI-AALA)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-010-04
Enrollment
10
Registered
2004-05-17
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

amlodipine / atorvastatin 5mg / 10mg Type of group
Amlodipine / atorvastatin 5mg / 10mg will be administered for 14 weeks Group name:Amlodipine / atorvastatin 10mg / 80mg Type of group
Amlodipine / atorvastatin 10mg / 80mg will be administered for 14 weeks

Sponsors

PFIZER S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Clinical diagnosis of high blood pressure and low density lipoprotein cholesterol levels, which require medication.

Exclusion criteria

Exclusion criteria: Patients with blood pressure maintained adequately to the target with or without medication Patients currently receiving treatment with amlodipine and atorvastatin or who are not at blood pressure or lipid level while taking the highest dose of amlodipine or atorvastatin, respectively

Design outcomes

Primary

MeasureTime frame
Outcome name:Levels of blood pressure and lipids. Measure:The therapeutic efficacy of amlodipine / atorvastatin by evaluation of the percentage of subjects trying to treat, who achieve the goals of treatment of both blood pressure and lipids Timepoints:14 day

Secondary

MeasureTime frame
Outcome name:summary of serious adverse events (EASs) or other available safety information including all serious unexpected adverse events related to the drug Measure:To assess the safety of dual therapy with titration of the doses of amlodipine and atorvastatin to achieve therapeutic goals in TA and LDL-C. Timepoints:throughout the study

Countries

Arabia Saudi, Argentina, Australia, Brazil, Chile, Guatemala, India, Indonesia, Israel, Korea North, Mexico, Morocco, Pakistan, Peru, Philippines, Singapore, South Africa, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates

Outcome results

None listed

Source: REPEC (via WHO ICTRP)