HypertensionPhase 4NCT00847834

Irbesartan-Hydrochlorothiazide Phase IV Study: Treatment of Hypertension in Chinese Population

A Phase 4 study testing Irbesartan 150mg / Hydrochlorothiazide 12.5mg and Irbesartan 150mg in people with Hypertension, run by Sanofi at 1 site in China.

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

To analyse the control rate of irbesartan/hydrochlorothiazide(HCTZ) (COAPROVEL) in the treatment of patients with mild to moderate primary hypertension. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hypertension
What is being tested?: Irbesartan 150mg / Hydrochlorothiazide 12.5mg and Irbesartan 150mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 968 participants
Where: 1 siteChina
Study dates: Dec 2003to Jun 2004
Phase: Phase 4
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Systolic blood pressure < 180 mmHg
90 mmHg ≤ Diastolic blood pressure < 110 mmHg

Who cannot join

Pregnancy or lactation. Women of child bearing potential (not post-menopausal) should be using a reliable contraceptive method
Known or suspected secondary hypertension (e.g., coarctation of aorta, renovascular stenosis, etc.)
Presence of clinically significant ventricular or supraventricular arrhythmias, or second or third degree atrioventricular block, or sick sinus syndrome
ALAT[SGPT]>2 times of upper limit，
ASAT[SGOT]>2 times of upper limit
Patients with known renal disease

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Serum potassium > normal upper limit
Uncontroled BD（FBG>10mmol/L or PBG>12.22mmol/L)
Patients treated with tricyclic antidepressants
Clinical hematological disease.
Patients with a history of irbesartan, or hydrochlorothiazide sensitivity defined as irbesartan, or hydrochlorothiazide discontinuation due to medically significant adverse effects.
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.

China1 site

Sanofi aventis administrative office
Beijing

Other trials in China

About this study

Official title: Multi-center Open Label, Non-comparative Observational Study of Irbesartan-Hydrochlorothiazide in the Treatment of Hypertension in Chinese Population

To analyse the control rate of irbesartan/hydrochlorothiazide(HCTZ) (COAPROVEL) in the treatment of patients with mild to moderate primary hypertension.

Conditions: Hypertension
Being tested: Irbesartan 150mg / Hydrochlorothiazide 12.5mg, Irbesartan 150mg
Medical subject headings: Hypertension

What participants receive

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

Irbesartan 150mg / Hydrochlorothiazide 12.5mgDrug
Once a day
Irbesartan 150mgDrug
Once a day

Study groups in NCT00847834
Study group	Role	What they receive
1	Experimental	4 weeks of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg followed by: * If DBP<85mmHg: 4 weeks of one tablet of Irbesartan 150mg / Hydrochlorothiazide 12.5mg * If DBP≥85mmHg: 4 weeks of one tablet of Irbesartan 150mg / Hydrochlorothiazide 12.5mg + one tablet of Irbesartan 150mg Receives: Drug: Irbesartan 150mg / Hydrochlorothiazide 12.5mg; Drug: Irbesartan 150mg
2	Experimental	2 weeks of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg followed by 2 weeks of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg + one tablet Irbesartan 150mg followed by: * If DBP<85mmHg: 4 weeks of of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg + one tablet Irbesartan 150mg * If DBP≥85mmHg: 4 weeks of two tablets Irbesartan 150mg / Hydrochlorothiazide 12.5mg Receives: Drug: Irbesartan 150mg / Hydrochlorothiazide 12.5mg; Drug: Irbesartan 150mg

What is being measured

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

Proportion of patients who reach a diastolic blood pressure <85 mmHg
Measured: At 2, 4 and 8 weeks

Timeline

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

Dec 2003Jun 2004

First posted19 Feb 2009 (estimated)
Study startDec 2003
Primary completionJun 2004

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 4
Primary purpose: Treatment
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 968 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00847834
Sponsor's protocol ID: L_9292
Status last verified: Sep 2009
First submitted: 18 Feb 2009
Last updated: 15 Sep 2009
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?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-center Open Label, Non-comparative Observational Study of Irbesartan-Hydrochlorothiazide in the Treatment of Hypertension in Chinese Population
ClinicalTrials.gov ID: NCT00847834
Acronym / sponsor ID: L_9292
Conditions: Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 968 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: Dec 2003
Primary completion: Jun 2004 (actual)
First posted: 19 Feb 2009 (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.

To analyse the control rate of irbesartan/hydrochlorothiazide(HCTZ) (COAPROVEL) in the treatment of patients with mild to moderate primary hypertension.

Study design

Primary purpose: Treatment
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Irbesartan 150mg / Hydrochlorothiazide 12.5mg, Drug: Irbesartan 150mg4 weeks of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg followed by: * If DBP<85mmHg: 4 weeks of one tablet of Irbesartan 150mg / Hydrochlorothiazide 12.5mg * If DBP≥85mmHg: 4 weeks of one tablet of Irbesartan 150mg / Hydrochlorothiazide 12.5mg + one tablet of Irbesartan 150mg
2	Experimental	Drug: Irbesartan 150mg / Hydrochlorothiazide 12.5mg, Drug: Irbesartan 150mg2 weeks of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg followed by 2 weeks of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg + one tablet Irbesartan 150mg followed by: * If DBP<85mmHg: 4 weeks of of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg + one tablet Irbesartan 150mg * If DBP≥85mmHg: 4 weeks of two tablets Irbesartan 150mg / Hydrochlorothiazide 12.5mg

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Systolic blood pressure < 180 mmHg
90 mmHg ≤ Diastolic blood pressure < 110 mmHg

Key exclusion criteria (12 listed)

Pregnancy or lactation. Women of child bearing potential (not post-menopausal) should be using a reliable contraceptive method
Known or suspected secondary hypertension (e.g., coarctation of aorta, renovascular stenosis, etc.)
Presence of clinically significant ventricular or supraventricular arrhythmias, or second or third degree atrioventricular block, or sick sinus syndrome
ALAT[SGPT]>2 times of upper limit，
ASAT[SGOT]>2 times of upper limit

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 150mg / Hydrochlorothiazide 12.5mgOnce a day	Drug	1, 2
Irbesartan 150mgOnce a day	Drug	1, 2

Primary outcome

Proportion of patients who reach a diastolic blood pressure <85 mmHg
Time frame: At 2, 4 and 8 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 15 Sep 2009.

Related trials for Hypertension

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Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
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Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
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.

Ji Jing 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 4 study testing Irbesartan 150mg / Hydrochlorothiazide 12.5mg and Irbesartan 150mg in people with Hypertension, run by Sanofi at 1 site in China.

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 2 inclusion and 12 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 15 Sep 2009. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 who reach a diastolic blood pressure <85 mmHg (time frame: At 2, 4 and 8 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 NCT00847834.

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 15 Sep 2009; AzTrials last refreshed its copy on 8 Nov 2026.