New combo pill for high blood pressure trial pulled before start
NCT ID NCT02493322
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study was designed to test whether a new fixed-dose combination of two blood pressure medicines (olmesartan and chlorthalidone) works as well as an existing combination (olmesartan and hydrochlorothiazide) in people with untreated high blood pressure. The trial was withdrawn before any participants were enrolled, so no data were collected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- olmesartan medoxomil + chlorthalidone (fixed-dose combination)
- What this could lead to
- If successful, this could offer a new once-daily pill option for controlling high blood pressure.
- What could go wrong
- The trial was withdrawn before enrolling any participants, so no results are available. It is unclear if the combination would have been safer or more effective than existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Signed Consent of the patient; * Participants with decompensated essential hypertension, classified into stage 1 (with high or very high cardiovascular risk), stage 2 or stage 3 according to the Brazilian Society of Cardiology (2010), who have never been treated and have indication for drug combination treatment. Obs: The diagnosis may be established by previous evaluation of two blood pressure measures ≥ 140/90 mmHg, with two months difference between measurements Exclusion Criteria: * Patients with any clinically significant disease that in the investigator is opinion can not participate in the study; * Secondary hypertension diagnosis or blood pressure above 190x100 mmHg in the screening/randomization visit; * Morbid obesity or immunocompromised patients; * Participants with greater than 10 mmHg difference in the measurements of systolic or diastolic blood pressure between the two arms; * Participants who do not have the two upper limbs; * Participants with important electrocardiographic changes; * Creatinine clearance - less than 60 mL /min; * History of hypertensive emergencies and cardiovascular and / or moderate to severe cerebrovascular events in the past 6 months; * Microalbuminuria in urine sample greater than 30 mg/g; * Patients with history of hypersensitivity to any of the formula compounds; * Pregnancy or risk of pregnancy and lactating patients; * Participation in clinical trial in the year prior to this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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