Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan or Amlodipine Monotherapy

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625494
• Other study ID #: IRBES_L_05887
• Secondary ID: U1111-1117-9116
• Status: Completed
• Phase: Phase 3
• First received: June 19, 2012
• Last updated: January 17, 2013
• Start date: May 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Irbesartan/Amlodipine (150/5mg)
Pharmaceutical form: tablet Route of administration: oral
• Irbesartan/Amlodipine (150/10mg)
Pharmaceutical form: tablet Route of administration: oral
• Irbesartan/Amlodipine (300/5mg)
Pharmaceutical form: tablet Route of administration: oral
• Irbesartan/Amlodipine (300/10mg)
Pharmaceutical form:tablet Route of administration: oral

Locations

Country	Name	City	State
Russian Federation	Sanofi-Aventis Administrative Office	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with controlled OBPM (SBP<140 mmHg and DBP<90 mmHg) at the end of the study		up to 16 weeks	No
Secondary	Proportion of patients with controlled OBPM by visit and treatment group	at Visit 3 (Week 8), at Visit 4 (Week 12) and at Visit 5 (Week 16)	up to 16 weeks	No
Secondary	Mean change in OBPM between 2 visits	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)	up to 16 weeks	No
Secondary	Number of patients with adverse events		up to 16 weeks	Yes
Secondary	Number of patients who discontinue from the study due to adverse events		up to 16 weeks	Yes
Secondary	Number of patients with abnormal liver function	As measured by AST, ALT, total bilirubin and serum creatinine	up to 16 weeks	Yes