Pharmacogenomic Evaluation of Antihypertensive Responses
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ClinicalTrials.gov Identifier: NCT00246519 |
Recruitment Status :
Completed
First Posted : October 30, 2005
Results First Posted : July 10, 2013
Last Update Posted : May 7, 2018
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Condition or disease | Intervention/treatment | Phase |
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Hypertension | Drug: Hydrochlorothiazide Drug: Atenolol | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1701 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR) |
Study Start Date : | October 2005 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
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Experimental: Atenolol
atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
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Drug: Atenolol
atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
Other Names:
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Experimental: Hydrochlorothiazide (HCTZ)
HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
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Drug: Hydrochlorothiazide
atenolol 50 or 100 mg hydrochlorothiazide 12.5 or 25 mg
Other Names:
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- Blood Pressure Response (Delta BP (After 18 Weeks of Medication - Baseline)). [ Time Frame: baseline to 18 weeks of treatment ]
- Adverse Metabolic Responses [ Time Frame: 9-18 weeks of treatment ]

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Ages Eligible for Study: | 17 Years to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
An average seated home diastolic blood pressure (DBP) > 85 mmHg and home systolic blood pressure (SBP) < 180 mmHg. Subjects must also have an average seated (> 5 minutes) clinic DBP between 90 mmHg and 110 mmHg and SBP < 180 mmHg
Exclusion Criteria:
secondary forms of HTN, patients currently treated with three or more antihypertensive drugs, isolated systolic HTN, other diseases requiring treatment with BP lowering medications, heart rate < 55 beats/min, known cardiovascular disease (including history of angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial infarction or revascularization procedure, or cerebrovascular disease, including stroke and TIA), diabetes mellitus (Type 1 or 2), renal insufficiency (serum creatinine > 1.5 in men or 1.4 in women), primary renal disease, pregnancy or lactation, liver enzymes > 2.5 upper limits of normal, current treatment with NSAIDS, cyclooxygenase-2 (COX2) inhibitors, oral contraceptives or estrogen.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246519
United States, Florida | |
University of Florida Department of Community Health and Family Medicine | |
Gainesville, Florida, United States, 32610 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Julie A Johnson, PharmD | University of Florida |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00246519 |
Other Study ID Numbers: |
U01GM074492 ( U.S. NIH Grant/Contract ) |
First Posted: | October 30, 2005 Key Record Dates |
Results First Posted: | July 10, 2013 |
Last Update Posted: | May 7, 2018 |
Last Verified: | April 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
hypertension pharmacogenetics pharmacogenomics beta-blocker atenolol |
diuretic hydrochlorothiazide blood pressure metabolic adverse effects |
Hypertension Vascular Diseases Cardiovascular Diseases Atenolol Metoprolol Hydrochlorothiazide Trichlormethiazide Antihypertensive Agents Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents |