None listed
Conditions
Interventions
Epoch 1 - Screening:
At the first study visit, subjects will be screened for the trial. If they qualify they will proceed
to Epoch 2 at the same clinic appointment.
Epoch 2 - Washout:
This
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study have to fulfill all of the following criteria: 1. Written informed consent must be obtained before any assessment is performed 2. Male or female patients > 18 years of age 3. Patients with mild-to-moderate essential hypertension, untreated or currently taking antihypertensive therapy a. Untreated patients (either newly diagnosed or those patients with a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to Visit 1) must have an office msSBP ≥ 150 mmHg and < 180 mmHg at both Visit 1 and Visit 201 b. Pretreated patients (using antihypertensive treatment within 4 weeks prior to Visit 1) must have an office msSBP ≥ 145 mmHg and < 180 mmHg after washout at Visit 201 4. Patients that are not adequately responsive to olmesartan treatment: all patients must have an office msSBP ≥ 145 mmHg and < 180 mmHg at the completion of the 4-week olmesartan 20 mg active run-in epoch (at the randomization visit (Visit 301)). 5. Patients must successfully complete ABPM and pass technical requirements at Visit 301 to be qualified for randomization 6. Ability to communicate and comply with all study requirements and demonstrate good medication compliance (≥ 80% compliance rate) during the run-in epoch
Exclusion criteria
Exclusion criteria: Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients. 1. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 5 times the terminal half-life of study treatment. Effective contraception methods include: • Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment • Male sterilization (at least 6 m prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject • Combination of any two of the following (a+b or a+c, or b+c): a. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception • In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment b. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
Countries
Argentina, Guatemala, Peru, Philippines, Russian Federation, Spain, United States, Venezuela
Contacts
Public ContactFiorella Ramirez
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed