Hypertension
Conditions
Keywords
Hypertension
Brief summary
This study is being conducted to evaluate the safety and antihypertensive efficacy of MK-0954A (Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg) in participants with mild to moderate essential hypertension.
Interventions
DRUGLosartan 50 mg / HCTZ 12.5 mg
Losartan 50 mg / HCTZ 12.5 mg tablet once daily for 12 weeks
Sponsors
Organon and Co
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant will have reached the legal age by the time of entrance into the run-in period. * Participant has no active medical problem, other than essential hypertension, which might of itself or by this treatment significantly affect the Participant's blood pressure. \- Participants diagnosed with mild to moderate essential hypertension or hypertension accompanying with established cardiovascular (CV) and renal diseases who are receiving antihypertensive regimen (exclude diuretic), yet not attaining to treatment goal\*. \* Note: For essential hypertension, the goal is to reduce the blood pressure to less than 140/90. For hypertension with established CV and renal diseases, the BP goal is \< 130/80. (According to 2007 European Society of Hypertension (ESH) - European Society of Cardiology (ESC) guideline) * Participant is either receiving antihypertensive therapy or no treatment. * Participants with stable diabetes mellitus may enter the study.
Exclusion criteria
* Pregnant or lactating females. * Secondary hypertension of any etiology (such as unilateral or bilateral renal disease, renal artery stenosis, coarctation of the aorta, pheochromocytoma). * History of malignant hypertension. * Sitting systolic blood pressure \>210 mmHg at Visit 1 (Day 0). * Participants with unresolved cerebrovascular accident or transient ischemic attack in the acute stage at visit 1. * A clinically confirmed myocardial infarction within the recent 3 months. * Angina pectoris. * Clinically important cardiac arrhythmia. * History of unexplained syncope within the prior 2 years, or a known syncopal disorder. \- Presence of hemodynamically significant obstructive valvular disease of cardiomyopathy. * Percutaneous coronary angioplasty or coronary artery bypass surgery within the prior 3 months of visit 1. * Participant with a single functioning kidney.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | At Baseline and Week 12 | Participants with SiDBP of 95-115 mmHg at the end of Baseline had SiDBP measured after 12 weeks of treatment. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Losartan 50 mg / HCTZ 12.5 mg Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / HCTZ 12.5 mg once-a-day for 12 weeks. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Unable to Follow Protocol Procedures | 1 |
Baseline characteristics
| Characteristic | Losartan 50 mg / HCTZ 12.5 mg |
|---|---|
| Age, Continuous | 50.5 years STANDARD_DEVIATION 6.7 |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
Participants with SiDBP of 95-115 mmHg at the end of Baseline had SiDBP measured after 12 weeks of treatment.
Time frame: At Baseline and Week 12
Population: Intention-to-Treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Losartan 50 mg / HCTZ 12.5 mg | Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Baseline (N = 15) | 99.2 mm Hg | Standard Deviation 5.5 |
| Losartan 50 mg / HCTZ 12.5 mg | Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Change from Baseline at Week 12 (N = 13) | -12.7 mm Hg | Standard Deviation 3.2 |
Comparison: Comparison of Week 12 and Baselinep-value: <0.05t-test, 2 sided