Pharmacogenomic Evaluation of Antihypertensive Responses 2 (PEAR2)
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ClinicalTrials.gov Identifier: NCT01203852 |
Recruitment Status
:
Completed
First Posted
: September 16, 2010
Results First Posted
: May 19, 2015
Last Update Posted
: April 6, 2018
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Condition or disease | Intervention/treatment | Phase |
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Hypertension | Drug: Metoprolol Drug: Chlorthalidone | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 839 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pharmacogenomic Evaluation of Antihypertensive Responses 2 |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | April 2014 |
Actual Study Completion Date : | April 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Metoprolol + Chlorthalidone
Study participants in this group had their current hypertension treatment withdrawn, baseline labs drawn and hypertension documented. Participants were initiated on metoprolol tartrate 50 mg twice daily for two weeks, followed by dose titration to 100 mg twice daily for six additional weeks if blood pressure (BP) > 120/70 mmHg. BP measures were again recorded. Participants entered a washout where metoprolol was titrated, then discontinued, and the patient's hypertension was re-established. After another set of identical baseline labs, study participants were initiated on chlorthalidone 25 mg four days per week (Monday, Wednesday, Thursday, Saturday) 15 mg daily for two weeks, followed by 25 mg daily for an additional six weeks.
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Drug: Metoprolol
Metoprolol 50 mg twice daily titrated to 100 mg twice daily Note: due to discontinuation of the manufacture of chlorthalidone 15 mg, effective Jan 1, 2013; the starting dose of chlorthalidone will be 25 mg 4 times per week (Mon, Wed, Thur, Sat) with subsequent titration to 25 mg daily. Other Names:
Drug: Chlorthalidone
Chlorthalidone 25 mg 4 times per week titrated to 25 mg daily
Other Name: Thalitone
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- Change in Blood Pressure From Baseline to Treatment [ Time Frame: after 6-8 weeks of treatment ]Response to blood pressure medication will be assessed by measuring blood pressure before and after treatment
- Adverse Metabolic Effects [ Time Frame: after 6-8 weeks treatment ]Change in glucose after treatment with study medication

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- An average seated home diastolic blood pressure (DBP) > 85 mmHg and < 110 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 hypertension (HTN) (including sleep apnea)
- Isolated systolic HTN
- Other diseases requiring treatment with BP lowering medications
- Heart rate < 55 beats/min (for metoprolol only)
- 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): NCT01203852
United States, Florida | |
University of Florida | |
Gainesville, Florida, United States, 32610 | |
United States, Georgia | |
Emory University School of Medicine | |
Atlanta, Georgia, United States, 30322 | |
United States, Minnesota | |
Mayo Clinic, Division of Hypertension | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Julie A Johnson, PharmD | University of Florida |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT01203852 History of Changes |
Other Study ID Numbers: |
IRB201700661-N U01GM074492-06 ( U.S. NIH Grant/Contract ) |
First Posted: | September 16, 2010 Key Record Dates |
Results First Posted: | May 19, 2015 |
Last Update Posted: | April 6, 2018 |
Last Verified: | April 2018 |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by University of Florida:
hypertension antihypertensive drug pharmacogenetics |
genetics blood pressure glucose |
Additional relevant MeSH terms:
Hypertension Vascular Diseases Cardiovascular Diseases Metoprolol Antihypertensive Agents Chlorthalidone Anti-Arrhythmia Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Diuretics Natriuretic Agents Sodium Chloride Symporter Inhibitors Membrane Transport Modulators |