None listed
Conditions
Interventions
placebo
Type of group
Patients will orally ingest 5 blind tablets daily from a coded pack of the study medication, once a day, between 6 a.m. and 10 a.m.
Group name:Hidroclorotiazide 12,5 mg Type of group
Patients will orally ingest 5 blind tablets daily from a coded pack of the study medication, once a day, between 6 a.m. and 10 a.m.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: a. Between 25 and 74 years of age. b. Sex: Patients of both sexes are accepted. c. Hospitalization status: Outpatient. d. The patient suffers from essential hypertension. e. According to a report prepared by the individual himself, the patient is of Japanese descent and his 4 biological grandparents were born in Japan and are descendants of Japanese.
Exclusion criteria
Exclusion criteria: a. The patient is pregnant or is breastfeeding. b. It has been confirmed or suspected that the patient suffers from secondary hypertension of any etiology. c. The patient has a history of malignant hypertension or current evidence of impending or active malignant hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The primary efficacy parameter in this study will be the change in the mean PADSe in the valley after 8 weeks of double-blind treatment. Measure:To evaluate the antihypertensive efficacy of 3 combinations of losartan (L, MK-0954) and hydrochlorothiazide (HCTZ, H) (L50 mg / H12.5 mg, L50 mg / H6.25 mg, L25 mg / H6.25 mg) compared to that of losartan alone (50 mg), HCTZ alone (12.5 mg) and placebo in patients with essential hypertension after 8 weeks of therapy. Timepoints:Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The safety of the combination of losartan and HCTZ will be assessed by evaluating the incidences of adverse experiences (AD) and adverse reactions (AD related to the drug). In addition, the posture change will be evaluated (from PA in supine position to stopped position), pulse, ECG (electrocardiogram), weight and laboratory values. Measure:To evaluate the safety and tolerability of losartan / HCTZ combinations, by evaluating adverse experiences and adverse reactions, after 8 weeks of therapy compared with losartan alone, HCTZ alone and placebo in patients with essential hypertension. Timepoints:Week 8 | — |
Countries
Japan, Peru
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed