Atenolol Exposure as Risk for Adverse Metabolic Responses to Beta Blockers
Information source: University of Florida
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Glucose (Other)
Phase: N/A
Status: Recruiting
Sponsored by: University of Florida Official(s) and/or principal investigator(s):
Julie A. Johnson, PharmD, Principal Investigator, Affiliation: University of Florida
Overall contact:
Julie A. Johnson, Pharm D., Phone: 352-273-6007, Email: johnson@cop.ufl.edu
Summary
The researchers hypothesize that the impact of increasing systemic exposure to atenolol
leads to increased risk for adverse metabolic effects from atenolol therapy in hypertension.
This will be accomplished through a 24-hour pharmacokinetic (PK) study and oral glucose
tolerance test in hypertensive patients taking chronic atenolol 100 mg daily.
Clinical Details
Official title: Atenolol Exposure as Risk for Adverse Metabolic Responses to Beta Blockers
Study design: Prevention, Open Label, Single Group Assignment, Pharmacokinetics Study
Primary outcome: Correlation of area under curve (AUC) up to 24 hour time point of atenolol plasma drug concentrations and glucose/insulin values obtained from OGTT and triglycerides
Secondary outcome: HDL-cholesterol, fatty acids, total cholesterol
Detailed description:
The current study is a sub-study of Pharmacogenomic Evaluation of Antihypertensive Responses
(PEAR - NCT00246519). The primary objective of this pharmacokinetic (PK) study is to
investigate the correlation of atenolol Cp with hypertriglyceridemia and insulin sensitivity
in mild to moderate hypertensive patients after 6-8 weeks of atenolol treatment.
Participants will undergo the PK study when they have been on atenolol 100 mg once daily for
at least 4 weeks and on atenolol therapy (50 mg or 100 mg) for ≥ 7 weeks. They will undergo
a two hour Oral Glucose Tolerance Test (OGTT), 1 hour after atenolol dosing. Blood will be
drawn at 12 time points for 24 hours. Atenolol Cp will be measured in all 12 blood samples
and will be correlated with the glucose/insulin measured during the OGTT.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects from PEAR who are on atenolol 100 mg once daily will be invited to
participate
- Other inclusion criteria from PEAR
Exclusion Criteria:
- Patients with BMI >35 kg/m2 will be excluded
- Other exclusion criteria from PEAR
Locations and Contacts
Julie A. Johnson, Pharm D., Phone: 352-273-6007, Email: johnson@cop.ufl.edu
University of Florida, Gainesville, Florida 32610, United States; Recruiting
Hrishikesh A. Navare, MS, Sub-Investigator
Reginald Frye, PharmD, PhD, Sub-Investigator
Whit Curry, MD, Sub-Investigator
Karen Hall, MD, Sub-Investigator
Crystal Comeau, MD, Sub-Investigator
Stephan Schmidt, MD, Sub-Investigator
Additional Information
Starting date: February 2008
Ending date: January 2010
Last updated: January 9, 2009
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