I SELECT - Irbesartan In Hypertensive Patients With Left... | NCT00362037

Studies
I SELECT - Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy

NCT00362037

Sponsor

Sanofi

Status

Completed

Last Update Posted

May 30, 2011Estimated

Enrollment

281Actual

Phase

Phase 4

Conditions

Hypertension

Interventions

Irbesartan (Aprovel)

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Aug 8, 2006

First Submission Date that Met QC Criteria

Aug 8, 2006

First Posted Date

Aug 9, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2011

Last Update Posted Date

May 30, 2011Estimated

Name	Class
Bristol-Myers Squibb	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

281Actual

Name	Type	Description	Arm Group Labels	Other Names
Irbesartan (Aprovel)	Drug	Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide one per day per os.

Measure	Description	Time Frame
Reduction in BP to target values according to the ESC 2003 Hypertension Guidelines		During the study conduct
Reduction in left ventricular hypertrophy from baseline values to week 36.		during the study conduct

Measure	Description	Time Frame
Occurrence of any side effect leading to treatment discontinuation.		During all the study conduct

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with proven mild to moderate Hypertension.
Patients must have left ventricular mass index > 130g/m2 in men, > 100g/m2 in women, as evidenced by echocardiography before inclusion.
Newly diagnosed "naïve" hypertensive patients (no prior treatment for hypertension). OR,
Patients who were receiving antihypertensive agents (maximum two agents including one diuretic) with blood pressure targets achieved, yet, in the investigator's opinion, those patients would benefit more from switching to the study medication. These patients will undergo a wash out period for not less than 7 days prior to enrollment.

Exclusion Criteria:

Severe hypertension (Systolic BP ≥ 180 mm Hg or Diastolic BP ≥ 110 mm Hg).
Patients with left ventricular ejection fraction < 45%.
Patients with severe left ventricular hypertrophy.
Patients with known secondary hypertension (for another cause other than type 2 Diabetes Mellitus).
Diabetic patients with HbA1c > 10%.
Significant chronic renal impairment (Serum creatinine > 2.0 mg/dL).
Significant liver disease as shown by SGPT/SGOT (ALT/AST) > 2.5 times the upper limit of the normal range.
Currently pregnant or lactating females.
Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.
Any patient who is in need for a combination antihypertensive therapy from the start (from the medical point of view of his/her physician).
Known hypersensitivity to irbesartan, other ARBs(Angiotensin Receptor Blockers), hydrochlorothiazide, or other thiazide diuretics.
Patients with malignancy during the past 5 years, known collagen disease or severe cardiac, cerebrovascular or gastric disease.

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic