Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan or Amlodipine Monotherapy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
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
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan or Amlodipine Monotherapy
