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Pharmacogenetic Prediction of Metoprolol Effectiveness

Information source: University of Colorado, Denver
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: metoprolol succinate (Drug); Genotyping (Genetic); CYP2D6 Phenotyping (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: University of Colorado, Denver

Official(s) and/or principal investigator(s):
Andrew Monte, MD, Principal Investigator, Affiliation: University of Colorado, Denver

Overall contact:
Andrew Monte, MD, Phone: 720-848-6777, Email: andrew.monte@ucdenver.edu

Summary

The investigators will prospectively follow a population of patients with uncontrolled high blood pressure beginning metoprolol succinate therapy to determine the drug effect in an observational clinical trial. The investigators will determine each individual's genotype for both CYP2D6 and ADRB1. Metabolomic markers will be identified to determine if specific metabolites are associated with drug response. The investigators' overall objective is to determine if genetics predicts metoprolol succinate response better than clinical factors such as age, race, body mass index, dose, and medication co-ingestion.

Clinical Details

Official title: Pharmacogenetic Prediction of Metoprolol Effectiveness

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Blood pressure decline

Secondary outcome:

Heart rate decline

Adverse Drug Events

Eligibility

Minimum age: 30 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Subjects between age >30 years and < 80 years 2. Subjects have diagnosis of uncontrolled essential hypertension. Exclusion Criteria: 1. end stage liver disease, 2. end stage renal disease, 3. pregnant females, 4. American Society of Anesthesiologists (ASA) classification of >3, 5. wards of the state, prisoners, 6. decisionally challenged, 7. HR<60 bpm, 8. AV block>240 msec, 9. active reactive airway disease, 10. illicit drug abuse in the preceding 30 days, 11. hypersensitivity to metoprolol or its derivatives 12. severe peripheral arterial circulatory disorders. Subjects will have a screening physical exam performed by Dr. Monte prior to enrollment in the study.

Locations and Contacts

Andrew Monte, MD, Phone: 720-848-6777, Email: andrew.monte@ucdenver.edu

University of Colorado Denver; Emergency Department, Aurora, Colorado 80045, United States; Recruiting
Hanna Flaten, BA, Phone: 303-724-7871, Email: hanna.flaten@ucdenver.edu
Andrew Monte, MD, Principal Investigator
Additional Information

Starting date: September 2014
Last updated: June 8, 2015

Page last updated: August 23, 2015

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