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

NCT00847834 | Completed Phase 4

• 1 other identifier: L_9292
• Study Type: interventional
• Target: 968
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who reach a diastolic blood pressure <85 mmHg

  At 2, 4 and 8 weeks

Study Arms (2)

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

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

Drug: Irbesartan 150mg / Hydrochlorothiazide 12.5mg; Drug: Irbesartan 150mg

Interventions

Irbesartan 150mg / Hydrochlorothiazide 12.5mg DRUG

Once a day

1; 2

Irbesartan 150mg DRUG

Once a day

1; 2

Eligibility Criteria

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

You may qualify if:

• Systolic blood pressure \< 180 mmHg
• mmHg ≤ Diastolic blood pressure \< 110 mmHg

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi aventis administrative office

Beijing, China

Location

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

• Ji Jing

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 18, 2009
• First Posted: February 19, 2009
• Study Start: December 1, 2003
• Primary Completion: June 1, 2004
• Last Updated: September 15, 2009

Record last verified: 2009-09

Locations

CN (1)