E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metabolic Syndrome, Hypertension |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052066 |
E.1.2 | Term | Metabolic syndrome |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020772 |
E.1.2 | Term | Hypertension |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the dose-dependent effect of OM 20 mg, 40 mg, and 80 mg on aortic stiffness assessed by: • The carotid-femoral Pulse Wave Velocity (PWV), up to 1 year of double-blind treatment • The carotid-femoral PWV, after adjustment for reduction of mean blood pressure (MBP) as measured at the same visit (up to 1 year of double-blind treatment) |
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E.2.2 | Secondary objectives of the trial |
To evaluate the dose-dependent effect of OM 20 mg, 40 mg, and 80 mg up to 1 year of double-blind treatment: • On Blood Pressure (BP) lowering, assessed by conventional BP measurement and 24h ambulatory BP measurement (24h-ABPM). • On central pulse pressure (PP) and augmentation index (AI). • On common carotid artery stiffness, intima-media thickness (IMT), and internal diameter.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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: a) BP ≥ 130/85 mmHg and < 150/95 mmHg (ie untreated high normal BP or “low range” mild hypertension) and at least 1 of the following traits at: • Abdominal obesity (waist circumference > 102 cm for men and > 88 cm for women) • Triglyceride level ≥ 150 mg/dL (≥ 1.7 mmol/L) • High Density Lipoprotein (HDL) < 40 mg/dL (< 1.0 mmol/L) for men and < 50 mg/dL (< 1.3 mmol/L) for women • Fasting blood glucose ≥ 110 mg/dL (≥ 6.1 mmol/L) and < 126 mg/dL (< 7 mmol/L) (ie no type 2 diabetes) Or b) BP ≥ 120/80 mmHg and < 130/85 mmHg (ie normal BP) and one antihypertensive treatment at Screening, and normal to “low range” mild hypertension (ie ≥ 130/85 and < 150/95 mmHg) at Baseline, and at least 1 of the following traits: • Abdominal obesity (waist circumference > 102 cm for men and > 88 cm for women) • Triglyceride level ≥ 150 mg/dL (≥ 1.7 mmol/L) • High Density Lipoprotein (HDL) < 40 mg/dL (< 1.0 mmol/L) for men and < 50 mg/dL (< 1.3 mmol/L) for women • Fasting blood glucose ≥ 110 mg/dL (≥ 6.1 mmol/L) and < 126 mg/dL (< 7 mmol/L) (ie no type 2 diabetes) Or c) BP ≥ 130/85 mmHg and < 150/95 mmHg (ie untreated high normal BP or “low range” mild hypertension) and current treatment with a lipid-lowering agent and at least 1 of the following traits: • Abdominal obesity (waist circumference > 102 cm for men and > 88 cm for women) • Fasting blood glucose ≥ 110 mg/dL (≥ 6.1 mmol/L) and < 126 mg/dL (< 7 mmol/L) (ie no type 2 diabetes) 4. No anti-hypertensive treatment or treatment with only one anti-hypertensive medication within the last 3 months (including ACE, ARB and renin-inhibitors). 5. Signature of the ICF
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E.4 | Principal 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 SBP: 150 - < 160 mmHg and/or 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 (criteria for metabolic syndrome; see Section 4.1.1), 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy endpoint Mean change in carotid-femoral PWV.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |