Clinical trial NCT01625494: Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan or Amlodipine Monotherapy
Official title: A Prospective Open-label Multicentre Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan 150 mg or Amlodipine 5 mg Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-06-21
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients with controlled OBPM (SBP<140 mmHg and DBP<90 mmHg) at the end of the study
timeFrame: up to 16 weeks
Secondary outcomes:
measure: Proportion of patients with controlled OBPM by visit and treatment group
timeFrame: up to 16 weeks
measure: Mean change in OBPM between 2 visits
timeFrame: up to 16 weeks
measure: Number of patients with adverse events
timeFrame: up to 16 weeks
measure: Number of patients who discontinue from the study due to adverse events
timeFrame: up to 16 weeks
measure: Number of patients with abnormal liver function
timeFrame: up to 16 weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: