MK0954A-264 Filter Study (0954A-264)(COMPLETED)

Phase 3

Completed

• Conditions: Mild to Severe Hypertension

• Registration Number: NCT00307060
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12-01
• Primary Completion: 2005-06-01
• Study Completion: 2005-06-02
• Study First Submitted: 2006-03-23
• Study First Submitted QC: 2006-03-23
• Study First Posted: 2006-03-27
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	6 Weeks

Secondary Outcome Measures

Name	Time	Method
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.	6 Weeks