Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan or Amlodipine Monotherapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Irbesartan/Amlodipine 150/5 mg fixed combination 1 tablet once daily in the morning for 4 weeks Patient will be first treated with irbesartan 150mg or amlodipine 5mg, 1 tablet /day for 4 weeks. If OBPM is controlled on monotherapy at week 4 (SBP <140 mmHg and DBP<90 mmHg), patient will be withdrawn from the study |
Drug: Irbesartan/Amlodipine (150/5mg)
Pharmaceutical form: tablet Route of administration: oral
|
| Experimental: Irbesartan/Amlodipine 150/10 mg fixed combination 1 tablet once daily in the morning for 4 weeks |
Drug: Irbesartan/Amlodipine (150/10mg)
Pharmaceutical form: tablet Route of administration: oral
|
| Experimental: Irbesartan/Amlodipine 300/5 mg fixed combination 1 tablet once daily in the morning for 4 weeks |
Drug: Irbesartan/Amlodipine (300/5mg)
Pharmaceutical form: tablet Route of administration: oral
|
| Experimental: Irbesartan/Amlodipine 300/10 mg fixed combination 1 tablet once daily in the morning for 4 weeks. If OBPM is controlled at week 12, patients will continue on the same therapy until the end of the study |
Drug: Irbesartan/Amlodipine (300/10mg)
Pharmaceutical form:tablet Route of administration: oral
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients with controlled OBPM (SBP<140 mmHg and DBP<90 mmHg) at the end of the study [up to 16 weeks]
Secondary Outcome Measures
- 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
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis Administrative Office | Moscow | Russian Federation |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRBES_L_05887
- U1111-1117-9116