MK0954A-264 Filter Study
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mild to Severe Hypertension
Intervention: MK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 6 weeks (Drug); losartan / Duration of Treatment: 6 weeks (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
To compare the blood pressure lowering efficacy, safety and tolerability of a combination
drug to a single drug taken once daily in patients with uncontrolled blood pressure following
a 4-week filter on the single therapy product.
Clinical Details
Official title: A Randomized, Double-Blind, Parallel-Filter Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan-HCTZ Combination as Compared to Losartan Monotherapy in Patients With Essential Hypertension
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Losartan-HCTZ 100-12.5 mg combination will be more effective in lower mean through sitting diastolic blood pressure (SiDBP) than losartan 100 mg monotherapy after 6 weeks of treatment.
Secondary outcome: Losartan-HCTZ 100-12.5 mg combination will be more effective in lowering mean through sitting systolic blood pressure (SiSBP) after 6 weeks of treatment compared to losartan 100-mg monotherapy, and will be safe and tolerable.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male and female patients with mild to severe hypertension (SiDBP 90-120 mmHg)
Exclusion Criteria:
- Systolic BP > 200 mmHg
- Secondary or malignant hypertension
- Taking more than 2 antihypertensive medications
- Hypertension induced by oral contraceptives
- Hx of cerebral vascular accident within 6 months
- Hx of angina, myocardial infarction, PCI, CABG, or decompensated CHF within 6 months
- Clinically significant AV conduction disturbance or potentially life threatening
ventricular arrhythmias, valvular disease, cardiomyopathy, unexplained syncope
- History of angioedema
- Sensitivity to AII receptor antagonists or HCTZ, nephrotic syndrome,single kidney
function
- Pregnancy or lactation.
Locations and Contacts
Additional Information
Related publications: Gleim GW, Rubino J, Zhang H, Shahinfar S, Soffer BA, Lyle PA, Littlejohn TW 3rd, Feig PU. A multicenter, randomized, double-blind, parallel-group trial of the antihypertensive efficacy and tolerability of a combination of once-daily losartan 100 mg/hydrochlorothiazide 12.5 mg compared with losartan 100-mg monotherapy in the treatment of mild to severe essential hypertension. Clin Ther. 2006 Oct;28(10):1639-48.
Starting date: December 2004
Last updated: October 9, 2007
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