Hypertension Circulatory System Essential (primary) hypertension
Conditions
Interventions
Patients will be submitted to a two-week run-in phase, where their previous medication will be replaced by placebo. At the end of run-in phase, patients will be randomly allocated in one of the treatm
Sponsors
Libbs Pharmaceutical Ltd (Brazil)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both sex, adults (> 18 years) 2. Established essential hypertension, untreated or treated but uncontrolled with treatment: 2.1. Office systolic blood pressure (SBP) 160-179 mmHg and diastolic blood pressure (DBP) 100-109 mmHg for untreated patients or patients already treated with combination drug 2.2. Office SBP 140-159 mmHg and DBP 100-109 mmHg for non-controlled patients treated with monotherapy
Exclusion criteria
Exclusion criteria: 1. Women of childbearing potential 2. Known hypersensitivity to drug study or angiotensin-converting enzyme inhibitors and/or diuretics 3. No-adhesion to treatment during run-in phase 4. Abnormal and clinically significant laboratory test results 5. Abnormal and clinically relevant ECG tracing 6. Pectoris Angina 7. Decompensate Congestive Heart Failure or that requires use of antagonists of renin-angiotesin-aldosteron system 8. Obesity with BMI over 35 kg/m2 9. Advanced or moderate hepatitis insufficiency 10. Decompensate or serious renal insufficiency. Creatinine clearance above 30 mL/min/1,73 m2 11. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease 12. Recent (< 6 months) or planned coronary revascularization 13. Cerebral vascular accident in the previous twelve months 14. Non controlled diabetes mellitus 15. Any serious or relevant disease at investigator criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in mean SBP and DPB as measured by ABPM from week 2 to week 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the changes in BP during 24-h ABPM at 8 weeks 2. To assess mean change in SBP and DBP from baseline to study end at 8 weeks 3. To assess the responder rate at 8 weeks 4. To asses the mean change from study baseline in office BP following eight weeks of treatment 5. Adverse events, vital signs, laboratory tests | — |
Countries
Brazil
Outcome results
None listed