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Evaluate the Safety and Anti-Hypertensive Efficacy of Hyzaar(R) In Patients With Mild To Moderate Essential Hypertension (0954A-323)

Evaluate the Safety and Tolerability of Hyzaar(R) (Losartan 50 Mg/ Hydrochlorothiazide 12.5 Mg) In the Treatment of Hypertension

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00400218
Enrollment
62
Registered
2006-11-16
Start date
2005-09-01
Completion date
2006-07-19
Last updated
2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

Evaluate the safety and anti-hypertensive efficacy of hyzaar(R) in patients with mild to moderate essential hypertension.

Interventions

DRUGMK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 12 Weeks

Sponsors

Organon and Co
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient is either receiving high blood pressure monotherapy or no treatment * Patient will have reached the legal age by the time enter the study * Patients diagnosed with mild to moderate essential high blood pressure or high blood pressure with other conditions such as diabetes or cardiovascular diseases and are taking high blood pressure medication (exclude diuretic), but did not meet treatment goal

Exclusion criteria

* Patient with high levels of uric acid in the blood who has received medications for uric acid in the urine within 3 months prior to enrollment * Patients who are hypersensitive to any component of the study medication * Patients who are hypersensitive to other sulfonamide-derived drugs * Patients with anuria (hyzaar(R) is not recommended for patients with hepatic impairment or severe renal impairment, creatinine clearance \</= 30 ml/min) * Unstable diabetes (hba1c \> 8%), or a change in diabetes medication during study treatment. patients with stable diabetes may enter the study.

Design outcomes

Primary

MeasureTime frame
Blood pressure over 12 weeks
Safety and Tolerability.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026