Mild to Severe Hypertension
Conditions
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.
Interventions
DRUGMK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 6 weeks
DRUGlosartan / Duration of Treatment: 6 weeks
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed