E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10015488 |
E.1.2 | Term | Essential 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 compare the efficacy in lowering mean trough sitting diastolic blood pressure (dBP) between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, assessed by conventional BP measurements, after eight weeks of double blind treatment, as compared to baseline. |
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E.2.2 | Secondary objectives of the trial |
•To evaluate the efficacy of OM/HCTZ 20/25 mg vs. 40/25mg, by measuring the change in mean trough sitting diastolic blood pressure (dBP) after four weeks of double-blind treatment compared to baseline; and systolic blood pressure (sBP) after four weeks and after eight weeks of double-blind treatment compared to baseline •To evaluate the number and percentage of patients in each treatment group achieving BP control (dBP < 90 mmHg and sBP < 140 mmHg for non-diabetics, and dBP < 80 mmHg and sBP < 130 mmHg for diabetics) after four weeks and after eight weeks of double blind treatment •To evaluate the antihypertensive efficacy, by measuring dBP and sBP, using 24 hour ambulatory blood pressure monitoring (ABPM) (daytime, nighttime and mean 24h ABPM) after eight weeks compared to baseline •To evaluate the risk-benefit ratio of OM/HCTZ 40/25 mg vs. 20/25 mg. •To evaluate the safety and tolerability of OM/HCTZ 20/25 mg vs. 40/25 mg combinations after eight weeks of double blind treatment
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female Europeans aged 18 years or older with moderate to severe HTN, defined as follows (conventional BP measurement): •Mean trough sitting BP of ≥ 160/100 mmHg, at Screening in patients not currently on antihypertensive medication. •Mean trough sitting BP of ≥ 140/90 mmHg at Screening in patients currently on antihypertensive medication. •Mean trough sitting BP of ≥ 160/100 mmHg in newly diagnosed patients or at the end of the taper off period in patients who have discontinued their previous antihypertensive medication, prior to entering open label treatment (Period I). •Mean trough sitting BP of ≥ 140/90 mmHg prior to entering open label treatment (Period I) in patients on a stable dose of OM 20 mg or 40 mg for at least four weeks. •A mean 24-hour dBP of at least 80 mmHg with at least 30% of daytime dBP readings over 85 mmHg for patients on stable OM 20 or 40 mg. •A mean 24-hour dBP of at least 85 mmHg with at least 30% of daytime dBP readings over 90 mmHg, for newly diagnosed patients or treated patients at the end of the taper-off period.
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E.4 | Principal exclusion criteria |
•Female patients of childbearing potential must not be pregnant or lactating or planning to become pregnant during the trial period. Female patients of childbearing potential must be using adequate contraception. •Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the study medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases. •Patients having a history of the following within the last six months: myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, hypertensive encephalopathy, cerebrovascular accident (stroke) or transient ischaemic attack. •Patients with clinically significant abnormal laboratory values at Screening. •Patients with secondary HTN of any aetiology such as renal disease, pheochromocytoma, or Cushing’s syndrome. •Patients with contraindication to HCTZ and/or OM. •Patients with mean sitting BP exceeding 200/120 mmHg (at Screening, Visit 1 or Visit 2), a mean 24-hour dBP exceeding 109 mmHg (at Visit 2) or bradycardia (< 50 beats/min at rest documented by mean radial PR or ECG, at Screening, Visit 1 or Visit 2).
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E.5 End points |
E.5.1 | Primary end point(s) |
To compare the efficacy in lowering mean trough sitting dBP between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, assessed by conventional BP measurements, after eight weeks of double-blind treatment, as compared to baseline (Visit 4, Week 8). |
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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 | Yes |
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 | Yes |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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) | Yes |
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 | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 52 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |