NCT00362258

Brief Summary

  • To evaluate Blood Pressure (BP) reduction to the targeted values (Systolic BP ≤ 130 mmHg and Diastolic BP ≤ 80 mmHg) in hypertensive type 2 diabetic patients.
  • To evaluate the benefit of Irbesartan in the reduction of microalbuminuria from baseline (if any at the inclusion visit) in this population.
  • To demonstrate the safety of Irbesartan in this population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
797

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started Feb 2006

Typical duration for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

April 4, 2011

Status Verified

March 1, 2011

Enrollment Period

2.6 years

First QC Date

August 8, 2006

Last Update Submit

April 1, 2011

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Reach blood pressure target in hypertensive diabetic patients i.e. 130/80 mmHg.

    During the study conduct

Secondary Outcomes (3)

  • The restoration of urinary albumin excretion (UAE) rate in patients with normoalbuminuria (UAE rate < 20µg / min)

    During the study conduct

  • First detection of overt nephropathy (UAE rate > 200µg / min), in patients with microalbuminuria or at least 30% higher than at baseline value(on at least two consecutive occasions)

    During the study conduct

  • Occurrence of any side effect leading to treatment discontinuation.

    During the study conduct

Interventions

Irbesartan (Aprovel)DRUG

Aprovel (150 \& 300mg) \& CoAprovel (300/12.5mg hydrochlorothiazide) one tablet/day per os.

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Proven Hypertensive Type 2 Diabetic Patients with HbA1c \> 6% and ≤ 10% (with or without microalbuminuria).
  • 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.

You may not qualify if:

  • Severe hypertension (SBP ≥ 180 mm Hg or DBP ≥ 110 mm Hg).
  • Patients with secondary hypertension.
  • Patients with UAE \> 200µg / min.
  • Patients with HbA1c \< 6% or \> 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/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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Cairo, Egypt

Location

MeSH Terms

Conditions

Hypertension

Interventions

Irbesartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSpiro CompoundsTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Mosaad I Morsi, MBBCh, MSc

    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

August 8, 2006

First Posted

August 9, 2006

Study Start

February 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

April 4, 2011

Record last verified: 2011-03

Locations

EG(1)