Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive Patients

NCT ID: NCT00670566

Last Updated: 2009-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

503 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Brief Summary

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The primary objective is to evaluate the antihypertensive efficacy of a fixed combination of Irbesartan/HydroChloroThiazide (CoAprovel) in Chinese moderate to severe hypertensive patients.

The secondary objective is to get systolic blood pressure and diastolic blood pressure goal attainment rate from CoAprovel in Chinese hypertensive patients.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

irbesartan/hydrochlorothiazide

Intervention Type DRUG

50/12.5mg for 4 weeks follow 300/12.5mg for 4 weeks and proceed to 300/25mg for 4 weeks

Interventions

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irbesartan/hydrochlorothiazide

50/12.5mg for 4 weeks follow 300/12.5mg for 4 weeks and proceed to 300/25mg for 4 weeks

Intervention Type DRUG

Other Intervention Names

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CoAprovel

Eligibility Criteria

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Inclusion Criteria

* Essential hypertensive patients
* Moderate to severe Patients with uncontrolled blood pressure (systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg for untreated, systolic blood pressure ≥150mmHg, diastolic blood pressure ≥95mmHg for treated on monotherapy).
* Patients are willing to discontinue previous antihypertensive medicine

Exclusion Criteria

* Pregnant or lactating women, or women of child bearing potential without contraceptive method.
* Hypersensitivity to any component of the products or other sulfonamide derived substances.
* Secondary hypertension.
* Severe renal impairment (Creatinine Clearance ≤30ml/min)
* Severe hepatic impairment, biliary cirrhosis and cholestasis.
* Refractory hypokalemia, hypercalcaemia.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Sanofi-aventis

Principal Investigators

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Mei Mao

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Administrative Office

Shanghai, , China

Site Status

Countries

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China

References

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Ye XF, Wang WY, Wang XY, Huang QF, Li Y, Wang JG. Alcohol Consumption and Antihypertensive Treatment Effect in Male Patients With Hypertension. Am J Hypertens. 2024 Jan 16;37(2):112-119. doi: 10.1093/ajh/hpad091.

Reference Type DERIVED
PMID: 37769181 (View on PubMed)

Other Identifiers

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IRBEH_L_03170

Identifier Type: -

Identifier Source: org_study_id

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