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

NCT00670566 | Completed Phase 4

• 1 other identifier: IRBEH_L_03170
• Study Type: interventional
• Target: 503
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Number of patients with controlled blood pressure

  At month 3

Secondary Outcomes (2)

• Adverse events

  Throughout the study period

• Systolic and Diastolic Blood Pressure

  At month 3 versus baseline

Study Arms (1)

1

EXPERIMENTAL

Drug: irbesartan/hydrochlorothiazide

Interventions

irbesartan/hydrochlorothiazide DRUG

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

Also known as: CoAprovel

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Shanghai, China

Location

Related Publications (1)

• 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.

  PMID: 37769181 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Irbesartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mei Mao

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 2, 2008
• Study Start: April 1, 2008
• Primary Completion: March 1, 2009
• Last Updated: September 15, 2009

Record last verified: 2009-09

Locations

CN (1)