| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | |
| MedDRA Classification |
| 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 | The primary objective of this study is to compare the proportion of subjects whose seated diastolic blood pressure (SeDBP) is controlled (SeDBP < 90mmHg) at Week 5 when initiating irbesartan 150mg/HCTZ 12.5mg combination therapy as first-line treatment (titrated to irbesartan 300mg/HCTZ 25mg), as compared to initiating irbesartan 150mg monotherapy and titrating to irbesartan 300mg.
| |
| E.2.2 | Secondary objectives of the trial | To characterize the safety/tolerability in the two treatment groups over the sevenweek study period, examining in particular the frequency of treatment
discontinuations due to adverse events, the frequencies of hypotension, dizziness and syncope, the frequency of headaches, and the frequencies of hypokalemia and
hyperkalemia. | |
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria | * Subjects must have uncontrolled hypertension defined as:
• currently untreated with an SeDBP ≥ 110mmHg
OR
• currently receiving antihypertensive monotherapy with an SeDBP ≥ 100mmHg.
Monotherapy is defined as treatment with one antihypertensive medication for at least four weeks; fixed combination therapy does not represent monotherapy.
* Subjects must be willing to discontinue their antihypertensive medication, if
applicable.
To qualify for randomization to double-blind therapy:
− all evaluations including laboratory testing from the Enrollment Visit must be
completed and the results must satisfy all selection criteria,
− blood pressure measurement of an averaged SeDBP ≥ 110mmHg must be
demonstrated at two consecutive visits (A01 and A99) off of medication and immediately prior to randomization (see Section 7.3.4 for BP standardization).
* Men and women, ages 18 and older will be included.
* WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity
25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study
medication. | |
| E.4 | Principal exclusion criteria | * SeSBP ≥ 220mmHg or SeDBP ≥ 130mmHg and/or evidence of malignant or
accelerated hypertension or clinical evidence that the subject requires immediate
lowering of his/her blood pressure within hours, including, but not limited to coronary
ischemia or neurological signs and symptoms.
* Known or suspected secondary hypertension.
* Hypertensive encephalopathy, stroke, or transient ischemic attack within the past 12 months
* Myocardial infarction, percutaneous transluminal coronary revascularization,
coronary artery bypass graft, or unstable angina pectoris within the past six months
* New York Heart Association functional class III-IV congestive heart failure, or LV
dysfunction requiring ACE inhibitor
* Hemodynamically significant cardiac valvular disease
* Heart block greater than first degree atrioventricular block, preexcitation syndrome,
sick sinus syndrome, chronic atrial fibrillation, or chronic atrial flutter, or other
significant arrhythmias that may interfere with the blood pressure measurements
* Significant chronic renal impairment, or renovascular disease
* Significant liver disease
* Systemic lupus erythematosus
* Obesity that would limit accurate blood pressure measurement
* Positive pregnancy test
* Serum creatinine > 1.5 mg/dL
* AST, ALT, or total bilirubin > 3 times the upper limit of normal
* Plasma glucose > 240 mg/dL (if high, may be repeated once)
* Hemoglobin A1c > 10%
* Serum potassium < 3.3 or > 5.5 mmol/l
* White blood cell count < 2,600/µl
* Platelet count < 100,000/µl
* Hb < 10g/dL | |
| E.5 End points |
| E.5.1 | Primary end point(s) | | The primary efficacy outcome measurements is the proportion of subjects with seated diastolic blood pressure less than 90 mmHg at the end of Week 5. | |
| 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 | No |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| 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) | 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.8.5 | The trial involves multiple Member States | Yes |
| 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 | |
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| 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 | | Total study duration is 8 weeks (including Placebo Lead-in). Scheduled visits are (A01, A99, B01, B02, B03, B99). Unscheduled visits may be performed at the Investigator's discretion. | |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 8 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 8 |
