Clinical trial NCT00500604: Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension
Official title: A Comparative Study of the Efficacy of Irbesartan/Hydrochlorothiazide 300/25 mg Versus Valsartan/Hydrochlorothiazide 160/25 mg Using Home Blood Pressure Monitoring in the Treatment of Mild to Moderate Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-07-12
Enrollment: 1617
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to compare the efficacy of irbesartan/hydrochlorothiazide 300/25mg against valsartan/hydrochlorothiazide 160/25mg in reducing mean systolic blood pressure (SBP) as measured by home blood pressure monitoring (HBPM) after 24 weeks compared with baseline.

The secondary objectives are:

* To compare the percentage of patients with normal blood pressure as measured by HBPM and at the doctor's office at weeks 16 and 24
* To compare the differences in mean Diastolic Blood Pressure (DBP), mean morning and evening SBP and DBP evaluated by HBPM at weeks 16 and 24
* To compare the difference in mean SBP evaluated by HBPM at week 16
* To compare the differences in mean SBP and DBP evaluated at the doctor's office at weeks 16 and 24
* To determine the incidence and severity of adverse events


Eligibility criteria: Inclusion Criteria:

* Established essential hypertension, untreated or treated but uncontrolled with treatment:

  * Office SBP ≥ 160 mmHg for untreated patients
  * Office SBP ≥ 140 mmHg for patients already treated with an antihypertensive drug.
* Previous antihypertensive therapy must have been implemented for a minimum of 4 weeks and must be either monotherapy or one of the following permitted combination drugs:

  * ACE inhibitor / calcium channel blocker
  * Beta blocker / calcium channel blocker
  * Beta blocker / low dose diuretic
  * ACE inhibitor / low dose diuretic

Exclusion Criteria:

* SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg evaluated at doctor's office at Visit 1
* Known or suspected causes of secondary hypertension
* Patient with bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, a renal transplant or only has one functioning kidney
* Type 1 diabetes mellitus
* Significant cardiovascular, neurological, endocrine, renal, metabolic, or gastrointestinal disease, a malignancy or any other diseases considered by the Investigator to make participation in the study not in the best interest of the subject
* Known hypersensitivity to diuretics or sulphonamides or history of angioedema or cough related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used
* Known contraindications to any of the study drugs
* Concomitant use of any other antihypertensive treatment
* Use of any of the investigational products for this study within the 3 months prior to the study
* Inability to obtain a valid HBPM recording i.e., obesity, arm circumference \> 32 cm or arrhythmia
* Administration of any other investigational drug in the last 30 days before enrolment and during the course of the study
* Pregnant or breast-feeding women
* 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

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

Primary outcomes:
measure: Reduction in mean SBP as measured by HBPM
timeFrame: From week 0 to week 24
Secondary outcomes:
measure: Reduction in mean DBP as measured by HBPM
timeFrame: From week 0 to weeks 16 and 24
measure: Reduction in mean morning and evening SBP as measured by HBPM
timeFrame: From week 0 to weeks 16 and 24
measure: Reduction in mean morning and evening DBP as measured by HBPM
timeFrame: From week 0 to weeks 16 and 24
measure: Reduction in mean SBP and mean DBP evaluated at the doctor's office
timeFrame: From week 0 to weeks 16 and 24
measure: Number of normalised patients as measured by HBPM
timeFrame: From week 0 to weeks 16 and 24
measure: Number of normalised patients evaluated at the doctor's office
timeFrame: From week 0 to weeks 16 and 24
measure: Reduction in mean SBP as measured by HBPM
timeFrame: From week 0 to week 16
measure: Adverse events, vital signs, laboratory tests
timeFrame: From visit 1 to end of study
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sanofi-Aventis Administrative Office
city: Hong Kong
country: Hong Kong
facility: Sanofi-Aventis Administrative Office
city: Mumbai
country: India
facility: Sanofi-Aventis Administrative Office
city: Jakarta
country: Indonesia
facility: Sanofi-Aventis Administrative Office
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis Administrative Office
city: Kuala Lumpur
country: Malaysia
facility: Sanofi-Aventis Administrative Office
city: Casablanca
country: Morocco
facility: Sanofi-Aventis Administrative Office
city: Karachi
country: Pakistan
facility: Sanofi-Aventis Administrative Office
city: Makati City
country: Philippines
facility: Sanofi-Aventis Administrative Office
city: Singapore
country: Singapore
facility: Sanofi-Aventis Administrative Office
city: Taipei
country: Taiwan
facility: Sanofi-Aventis Administrative Office
city: Bangkok
country: Thailand
facility: Sanofi-Aventis Administrative Office
city: Megrine
country: Tunisia
facility: Sanofi-Aventis Administrative Office
city: Ho Chi Minh City
country: Vietnam
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Benedict Blayney
role: STUDY_DIRECTOR
References: