Real Life Experience With Caduet In Patients With Cardiovascular Risk Factors

NCT00579254 | Terminated Results

• 1 other identifier: A3841054
• Study Type: observational
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the effect of single pill therapy on the management of hypertension and other cardiovascular risk factors (e.g., dyslipidemia) in Indian patients in whom the treating doctor has already considered that the administration of the amlodipine/atorvastatin single pill to be appropriate

Conditions

Hypertension and Cardiovascular Risk Factors

Keywords

Efficacy,safety & tolerability of Caduet In Patients With Cardiovascular Risk Factors

Outcome Measures

Primary Outcomes (1)

• Change in Systolic and Diastolic Blood Pressure

  No efficacy results were available from this terminated study.

  Baseline, 24 weeks

Interventions

CADUET (AMLODIPINE 5 mg/ATORVASTATIN 10 mg or 20 mg) DRUG

Patients who have been treated with Caduet 5/10 or 5/20 mg single pill treatment, based on their clinical conditions and latest locally approved packet insert recommendations will be eligible to be enrolled to this study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be treated in this study according to prevailing local clinical practice following the locally approved product labeled recommendations

You may qualify if:

• Patients who have been prescribed single pill Caduet are eligible to participate in this study. Patients will be treated in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.

You may not qualify if:

• Known hypersensitivity to dihydropyridines, amlodipine, atorvastatin, or any component of this medication,
• Active liver disease or unexplained persistent elevations of serum transaminases exceeding three times the upper limit of normal,
• Or who are pregnant, breast-feeding, or of childbearing potential who are not using adequate contraceptive measures. Amlodipine/atorvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards to the fetus.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hypertension

Interventions

amlodipine, atorvastatin drug combination; Amlodipine; Atorvastatin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Limitations and Caveats

The objectives for this terminated study could not be assessed due to limited data available. (Efficacy parameters were to include BP, heart rate, lipid profile, urine albumin.)

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 24, 2007
• Study Start: December 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: January 28, 2021
• Results First Posted: June 19, 2009

Record last verified: 2021-01