I SAVE - Irbesartan in Mild to Moderate Hypertensive Pati... | NCT00335673

Studies
I SAVE - Irbesartan in Mild to Moderate Hypertensive Patients

NCT00335673

Sponsor

Sanofi

Status

Completed

Last Update Posted

Apr 1, 2011Estimated

Enrollment

1,630Actual

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

Mar 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

Feb 2006

Primary Completion Date

Nov 2006Actual

Completion Date

Nov 2006Actual

First Submitted Date

Jun 9, 2006

First Submission Date that Met QC Criteria

Jun 9, 2006

First Posted Date

Jun 12, 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

Mar 31, 2011

Last Update Posted Date

Apr 1, 2011Estimated

Name	Class
Bristol-Myers Squibb	INDUSTRY

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

1,630Actual

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

Measure	Description	Time Frame
Reduction in blood pressure to target values according to ESC 2003 guidelines at the end of the study.		During the study conduct

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with proved mild to moderate hypertension.
Newly diagnosed "naïve" hypertensive patients (no prior treatment for hypertension)OR
Patients who were receiving antihypertensive agents (maximum two - one of them is diuretic) and who in the investigator's opinion 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 Blood Pressure ≥ 180 mm Hg or Diastolic Blood Pressure ≥ 110 mm Hg).
Patients with secondary hypertension (for another cause other than type 2 diabetes mellitus).
Patients with HbA1c > 10%.
Significant chronic renal impairment (Serum creatinine > 2.0 mg/dL).
Significant liver disease as shown by SGPT/SGOT (ALAT/ASAT) > 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 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