Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Losartan 50 mg / HCTZ 12.5 mg | Experimental | Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / HCTZ 12.5 mg once-a-day for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Losartan 50 mg / HCTZ 12.5 mg | Drug | Losartan 50 mg / HCTZ 12.5 mg tablet once daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Baseline and Week 12 |
Not provided
Not provided
Inclusion criteria:
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)
Exclusion criteria:
disease, renal artery stenosis, coarctation of the aorta, pheochromocytoma).
disorder.
- Presence of hemodynamically significant obstructive valvular disease of
cardiomyopathy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Du-Yi Lee, M.D. | Cheng Ching General Hospital | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Losartan 50 mg / HCTZ 12.5 mg | Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg once-a-day for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intention-to-Treat | Posted | Mean | Standard Deviation | mm Hg | At Baseline and Week 12 |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Losartan 50 mg/HCTZ 12.5 mg |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ARRHYTHMIA | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019808 | Losartan |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| 0 |
| 15 |
| 8 |
| 15 |
| PALPITATIONS | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| BLOOD CHOLESTEROL INCREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| BLOOD GLUCOSE ABNORMAL | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| BLOOD POTASSIUM DECREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| BLOOD SODIUM INCREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| BLOOD TRIGLYCERIDES INCREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| BLOOD UREA INCREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| BLOOD URIC ACID INCREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |