Hypertension
Conditions
Brief summary
Primary Objective: \- To assess the proportion of patients with controlled Office Blood Pressure Measurements (OBPM), defined as Systolic blood pressure \< 140 mmHg and Diastolic blood pressure \<90mmHg, at the end of the study Secondary Objectives: * To examine over time the antihypertensive effect of the 4 doses of the fixed combination therapy irbesartan/amlodipine on OBPM (SBP (systolic blood pressure) and DBP (diastolic blood pressure) * To examine the proportion of patients with controlled OBPM (systolic BP\<140 mm Hg and diastolic BP\<90 mmHg) of the different dose groups over time * To determine the incidence and severity of adverse events.
Detailed description
16 weeks * V1 (week 0): Inclusion visit. * V2 (Week 4): Irbesartan/amlodipine 150/5 mg fixed combination visit * V3 (Week 8): 1st dose escalation for patients in whom OBPM is not controlled (SBP ≥ 140 mmHg or DBP ≥ 90mmHg, * V4 (Week 12): 2nd Dose escalation visit for patients in whom OBPM is not controlled (SBP ≥ 140 mmHg or DBP ≥ 90mmHg * V5 (Week 16): End of study visit
Interventions
DRUGIrbesartan/Amlodipine (150/5mg)
Pharmaceutical form: tablet Route of administration: oral
DRUGIrbesartan/Amlodipine (150/10mg)
Pharmaceutical form: tablet Route of administration: oral
DRUGIrbesartan/Amlodipine (300/5mg)
Pharmaceutical form: tablet Route of administration: oral
DRUGIrbesartan/Amlodipine (300/10mg)
Pharmaceutical form:tablet Route of administration: oral
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: * Men and women ≥18 years old * Established essential hypertension * Treated with irbesartan 150 mg or amlodipine 5 mg as monotherapy for at least 2 weeks * With uncontrolled systolic BP (blood pressure) defined as ≥140 mm Hg assessed by OBPM (office blood pressure measurements) * Signed written informed consent obtained prior to inclusion to the study
Exclusion criteria
* Mean systolic BP ≥180 mm Hg and/or mean diastolic BP ≥110 mm Hg by OBPM on Visit 1 * Known or suspected causes of secondary hypertension * Patients with bilateral artery stenosis, renal artery stenosis in a solitary kidney, renal transplant or only has one functioning kidney * Known contraindications or hypersensitivity to either amlodipine or irbesartan or to the combination * History of angioedema related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used * Severe hepatic impairment (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \>5 times the upper normal limit (ULN) or history of hepatic encephalopathy, esophageal varices or portocaval shunt) * Severe renal impairment (glomerular filtration rate \<30 ml/min) * Concomitant use of any other antihypertensive treatment except of Irbesartan and Amlodipine * Administration of any other investigational drug within 30 days before inclusion * Presence of any other conditions that would restrict or limit the patient participation for the duration of the study * Pregnant or breast feeding women * Women of childbearing potential unable or unwilling to use an acceptable method to avoid pregnancy for the entire study period * Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with controlled OBPM (SBP<140 mmHg and DBP<90 mmHg) at the end of the study | up to 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with controlled OBPM by visit and treatment group | up to 16 weeks | at Visit 3 (Week 8), at Visit 4 (Week 12) and at Visit 5 (Week 16) |
| Mean change in OBPM between 2 visits | up to 16 weeks | Visit 2 (Week 4) and Visit 5 (Week 16), Visit 2 (Week 4) and Visit 4 (week 12), Visit 2 (Week 4) and Visit 5 (Week 16), Visit 3 (Week 8) and Visit 4 (Week 12), Visit 3 (Week 8) and Visit 5 (Week 16) |
| Number of patients with adverse events | up to 16 weeks | — |
| Number of patients who discontinue from the study due to adverse events | up to 16 weeks | — |
| Number of patients with abnormal liver function | up to 16 weeks | As measured by AST, ALT, total bilirubin and serum creatinine |
Countries
Russia
Outcome results
None listed