E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hypertension, metabolic syndrome |
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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 | SOC |
E.1.2 | Classification code | 10007541 |
E.1.2 | Term | Cardiac disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10027433 |
E.1.2 | Term | Metabolism and nutrition disorders |
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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 effect of olmesartan on aortic stiffness |
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E.2.2 | Secondary objectives of the trial |
To investigate the effect of olmesartan on blood pressure lowering, on central pulse pressure, and carotid intima-media thickness |
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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: 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, as BP ≥ 130/85 mmHg and < 150/95 mmHg (ie untreated high normal BP or low range mild hypertension) and at least 2 of the following traits at: Abdominal obesity (waist circumference > 102 cm for men and > 88 cm for women) Triglyceride level ≥ 150 mg/dL High Density Lipoprotein (HDL) < 40 mg/dL for men and < 50 mg/dL for women Fasting blood glucose ≥ 110 mg/dL and < 126 mg/dL (ie no type 2 diabetes) 4.No anti-hypertensive treatment or treatment with only one anti-hypertensive medication within the last 3 months. Note: treatment with Angiotensin II Receptor Blockers (ARB) or Angiotensin-Converting Enzyme Inhibitors (ACE) is not allowed within the last 6 months 5.Signature of the Informed Consent Form (ICF) |
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E.4 | Principal exclusion criteria |
Subjects who meet any one 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 snd/or ≥ 110 Resistant hypertension Hypertension resistant to treatment 5.Secondary hypertension of any aetiology, such as renal disease, pheocromocytoma, or Cushings syndrome 6.Inconsistent use of lipid-lowering agents (eg statins, fibrates) within 2 years prior to study start. Note: No use of lipid-lowering agents within 2 years is allowed. 7.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 8.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 9.Clinically relevant abnormal laboratory values 10.Contraindication to OM 11.Previously enrolled subjects 12.Alcohol or drug of abuse in the past 2 years 13.Planned hospitalization during the study period 14.Participation in any other clinical study within 30 days prior to Screening visit 15.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) |
Change from baseline 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 | Yes |
E.8.2.3.1 | Comparator description |
- same IMP used at different dosage |
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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 | 5 |
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
| |
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 |