HypertensionPhase 3NCT01625494

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

A Phase 3 study testing Irbesartan/Amlodipine (150/5mg), Irbesartan/Amlodipine (150/10mg) and Irbesartan/Amlodipine (300/5mg) in people with Hypertension, run by Sanofi at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: Irbesartan/Amlodipine (150/5mg), Irbesartan/Amlodipine (150/10mg) and Irbesartan/Amlodipine (300/5mg)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 158 participants
Where: 1 siteRussia
Study dates: May 2012to Jan 2013
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

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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.

Trial locations and contacts

1 site in 1 country.

Russia1 site

Sanofi-Aventis Administrative Office
Moscow

Other trials in Russia

About this study

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

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.

Read the 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

Conditions: Hypertension
Being tested: Irbesartan/Amlodipine (150/5mg), Irbesartan/Amlodipine (150/10mg), Irbesartan/Amlodipine (300/5mg), Irbesartan/Amlodipine (300/10mg)
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01625494
Study group	Role	What they receive
Irbesartan/Amlodipine 150/5 mg fixed combination	Experimental	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 Receives: Drug: Irbesartan/Amlodipine (150/5mg)
Irbesartan/Amlodipine 150/10 mg fixed combination	Experimental	1 tablet once daily in the morning for 4 weeks Receives: Drug: Irbesartan/Amlodipine (150/10mg)
Irbesartan/Amlodipine 300/5 mg fixed combination	Experimental	1 tablet once daily in the morning for 4 weeks Receives: Drug: Irbesartan/Amlodipine (300/5mg)
Irbesartan/Amlodipine 300/10 mg fixed combination	Experimental	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 Receives: Drug: Irbesartan/Amlodipine (300/10mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of patients with controlled OBPM (SBP<140 mmHg and DBP<90 mmHg) at the end of the study
Measured: up to 16 weeks

Secondary outcomes (5)

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)
Measured: up to 16 weeks
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)
Measured: up to 16 weeks
Number of patients with adverse events
Measured: up to 16 weeks
Number of patients who discontinue from the study due to adverse events
Measured: up to 16 weeks
Number of patients with abnormal liver function
As measured by AST, ALT, total bilirubin and serum creatinine
Measured: up to 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Jan 2013

First posted21 Jun 2012 (estimated)
Study startMay 2012
Primary completionJan 2013
Study completionJan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by SanofiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 158 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01625494
Sponsor's protocol ID: IRBES_L_05887
Other IDs: U1111-1117-9116
Status last verified: Jan 2013
First submitted: 19 Jun 2012
Last updated: 18 Jan 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01625494
Acronym / sponsor ID: IRBES_L_05887
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 158 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: May 2012
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 21 Jun 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Irbesartan/Amlodipine 150/5 mg fixed combination	Experimental	Drug: Irbesartan/Amlodipine (150/5mg)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
Irbesartan/Amlodipine 150/10 mg fixed combination	Experimental	Drug: Irbesartan/Amlodipine (150/10mg)1 tablet once daily in the morning for 4 weeks
Irbesartan/Amlodipine 300/5 mg fixed combination	Experimental	Drug: Irbesartan/Amlodipine (300/5mg)1 tablet once daily in the morning for 4 weeks
Irbesartan/Amlodipine 300/10 mg fixed combination	Experimental	Drug: Irbesartan/Amlodipine (300/10mg)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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Irbesartan/Amlodipine (150/5mg)Pharmaceutical form: tablet Route of administration: oral	Drug	Irbesartan/Amlodipine 150/5 mg fixed combination
Irbesartan/Amlodipine (150/10mg)Pharmaceutical form: tablet Route of administration: oral	Drug	Irbesartan/Amlodipine 150/10 mg fixed combination
Irbesartan/Amlodipine (300/5mg)Pharmaceutical form: tablet Route of administration: oral	Drug	Irbesartan/Amlodipine 300/5 mg fixed combination
Irbesartan/Amlodipine (300/10mg)Pharmaceutical form:tablet Route of administration: oral	Drug	Irbesartan/Amlodipine 300/10 mg fixed combination

Primary outcome

Proportion of patients with controlled OBPM (SBP<140 mmHg and DBP<90 mmHg) at the end of the study
Time frame: up to 16 weeks

5 secondary outcomes

Proportion of patients with controlled OBPM by visit and treatment group
Time frame: up to 16 weeks
Mean change in OBPM between 2 visits
Time frame: up to 16 weeks
Number of patients with adverse events
Time frame: up to 16 weeks
Number of patients who discontinue from the study due to adverse events
Time frame: up to 16 weeks
Number of patients with abnormal liver function
Time frame: up to 16 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.

Related trials for Hypertension

Active, not recruiting
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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Sciences & Operations study director

Sanofi

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Irbesartan/Amlodipine (150/5mg), Irbesartan/Amlodipine (150/10mg) and Irbesartan/Amlodipine (300/5mg) in people with Hypertension, run by Sanofi at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with controlled OBPM (SBP<140 mmHg and DBP<90 mmHg) at the end of the study (time frame: up to 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01625494.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2013.