Metabolic Syndrome, Hypertension MedDRA version: 9.1 Level: LLT Classification code 10052066 Term: Metabolic syndrome MedDRA version: 9.1 Level: LLT Classification code 10020772 Term: Hypertension
Conditions
Sponsors
DAIICHI SANKYO EUROPE GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must satisfy all of the following criteria at Screening visit (Visit 1) and at Baseline (Visit 2) to be included in the study; except inclusion criterion 3, which needs only be satisfied at the screening visit: 1. Male and female outpatients 2. Age = 18 and = 75 years 3. Hypertension and metabolic syndrome defined, according to the ATP III/ IDF 2005 and ESH/ESC 2007 definitions with modifications, as: a) BP = 130/85 mmHg and 102 cm for men and > 88 cm for women) • Triglyceride level = 150 mg/dL (= 1.7 mmol/L) • HDL 102 cm for men and > 88 cm for women) • Triglyceride level = 150 mg/dL (= 1.7 mmol/L) • HDL 102 cm for men and > 88 cm for women) • Fasting blood glucose = 110 mg/dL (= 6.1 mmol/L) and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria at Screening visit (Visit 1) or at Baseline (Visit 2) will be disqualified from entering the study: 1. Pregnant or lactating female (prerequisite for female subjects of childbearing potential: adequate contraception) 2. Type 1 and type 2 diabetes 3. “High range” mild hypertension (ie Systolic Blood Pressure [SBP]: 150 - < 160 mmHg and/or Diastolic Blood Pressure [DBP]: 95 - < 100 mmHg) 4. Moderate, severe, or resistant hypertension (see definitions below) SBP (mmHg) DBP (mmHg) Moderate hypertension 160 – 179 and/or 100 – 109 Severe hypertension = 180 and/or = 110 Resistant hypertension Hypertension resistant to treatment 5. Secondary hypertension of any aetiology, such as renal disease, pheocromocytoma, or Cushing’s syndrome 6. Serious disorders which may limit the ability to evaluate the efficacy or safety of the study drug, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine, metabolic, haematological, oncological, neurological, or psychiatric diseases 7. History of the following pathologies within the last 6 months: myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, hypertensive encephalopathy, stroke, or transient ischemic attack 8. Clinically relevant abnormal laboratory values 9. Contraindication to OM 10. Previously screened subjects, unless they failed inclusion criterion 3 at screening and/or baseline under earlier protocol requirements. 11. Alcohol or drug of abuse in the past 2 years 12. Planned hospitalization during the study period 13. Participation in any other clinical study within 30 days prior to Screening visit 14. Enrolment of the Investigator(s), site staff, or their family members
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate in a descriptive way the dose-dependent effect of OM 20 mg, 40 mg, and 80 mg on aortic stiffness assessed by • The change from baseline in carotid-femoral Pulse Wave Velocity (PWV) after 52 weeks of double-blind treatment • The change from baseline in carotid-femoral PWV, after adjustment for change from baseline in Mean Blood Pressure (MBP) after 52 weeks of double-blind treatment ;Secondary Objective: To investigate in a descriptive way the dose-dependent effect of OM 20 mg, 40 mg, and 80 mg • The change from baseline in carotid-femoral Pulse Wave Velocity (PWV) after 24 weeks of double-blind treatment • The change from baseline in carotid-femoral PWV, after adjustment for change from baseline in Mean Blood Pressure (MBP) after 24 weeks of double-blind treatment • On Blood Pressure (BP) lowering, assessed by conventional BP measurement and 24h Ambulatory BP Measurement (24h-ABPM) after 52 and 24 weeks of double-blind treatment • On central Pulse Pressure (PP) and Augmentation Index (AI) after 52 and 24weeks of double-blind treatment • On common carotid stiffness, Intima-Media Thickness (IMT), and internal diameter after 52 and 24weeks of double-blind treatment. ;Primary end point(s): Primary efficacy endpoint Change from baseline in carotid-femoral PWV at Week 52. | — |
Countries
Belgium, France, Germany, Italy, Netherlands, United Kingdom
Outcome results
None listed