| June 9, 2006 |
| September 24, 2009 |
| February 2006 |
| November 2006 (final data collection date for primary outcome measure) |
| Reduction in blood pressure to target values according to ESC 2003 guidelines at the end of the study. [ Time Frame: During the study conduct ] [ Designated as safety issue: No ] |
| Reduction in blood pressure to target values according to ESC 2003 guidelines at the end of the study. |
| Complete list of historical versions of study NCT00335673 on ClinicalTrials.gov Archive Site |
| Occurrence of any side effects leading to treatment discontinuation. [ Time Frame: During the study conduct ] [ Designated as safety issue: Yes ] |
| Occurrence of any side effects leading to treatment discontinuation. |
| |
| I SAVE - Irbesartan in Mild to Moderate Hypertensive Patients |
| Irbesartan in Mild to Moderate Hypertensive Patients |
- To evaluate control rate of Blood Pressure ≤ 140/90 mm Hg in non-diabetic patients, and ≤ 130/80 mm Hg in diabetic patients.
- To determine percentage of patients achieving blood pressure control according to their profile (naïve, switch, patient history, etc…) at the end of the trial.
|
| |
| Phase IV |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Hypertension |
| Drug: Irbesartan (Aprovel) |
| |
| |
| |
| Completed |
| 1754 |
|
| November 2006 (final data collection date for primary outcome measure) |
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. |
| Both |
| 30 Years to 75 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Egypt |
| |
| NCT00335673 |
| Medical Affairs Study Director, sanofi-aventis |
| IRBES_L_00165 |
| Sanofi-Aventis |
| Bristol-Myers Squibb |
| Study Director: |
Mosaad I Morsi, MBBCh, MSc |
Sanofi-Aventis |
|
|
| Sanofi-Aventis |
| September 2009 |
