Clinical trial NCT00546754: BP-EASE -Effectiveness of Losartan 50 mg/Hydrochlorothiazide (HCTZ) 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg Titrated as Needed in Patients With Essential Hypertension Not Controlled on Monotherapy (0954A-333)
Official title: BP-EASE-A 12-Week, Multicenter, Open-Label, Randomized, Controlled Trial To Compare The Effectiveness of Losartan 50 mg/HCTZ 12.5 mg Titrated as Needed to Losartan 100 mg/HCTZ 25 mg or Valsartan 160 mg/HCTZ 25 mg, in Patients With Essential Hypertension Who Have Not Achieved Target Blood Pressure With
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-10-19
Enrollment: 808
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the blood pressure efficacy between losartan and valsartan at equivalent dosage during a 3 months treatment.


Eligibility criteria: Inclusion Criteria:

* An Adult Patient 18 to 75 Years Of Age
* Patient with essential hypertension receiving an antihypertensive agent in monotherapy for at least 4 weeks for whom the antihypertensive agent can (and will) be discontinued and whose blood pressure is not controlled:
* Either systolic or diastolic blood pressure \> 140/90 mm Hg up to 180/110 mm Hg (inclusive)
* Either systolic or diastolic blood pressure \> 130/80 mm Hg up to 160/100 mm Hg (inclusive) for diabetic patients
* Patient is male or a female who is highly unlikely to conceive as she falls into one of the categories listed below:

  * Surgically sterilized female
  * Postmenopausal female \> 45 years of age with \> 2 years since her last menses
  * Non-sterilized pre-menopausal female who agrees to: (1) use 2 adequate methods of contraception to prevent pregnancy \[either 2 barrier methods or a barrier method plus a hormonal method\]; or (2) abstain from heterosexual activity throughout the study starting with Visit 1 and for 14 days after the last dose of study medication; or (3) only engage in heterosexual activity with surgically sterilized male partner(s) throughout the study starting with Visit 1 and for 14 days after the last dose of study medication
  * Patient judged to be in otherwise good, stable health on the basis of medical history and physical examination

Exclusion Criteria:

* Known secondary hypertension of any aetiology (e.g., uncorrected renal artery stenosis, malignant hypertension, or hypertensive encephalopathy)
* Patient Needing An Initiation Of A Lipid Lowering Agent Or A Modification Of His Lipid Therapy At Visit 1 Or During The Study Period (12 Weeks)
* Patient taking allopurinol
* Patient Previously Shown To Be Intolerant To Any Component Of Losartan Valsartan, Or HCTZ Or With A Documented History Of Angioedema/Anaphylaxis
* Patient With Confirmed Clinically Significant Renal Or Hepatic Dysfunction And/Or Electrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1: Serum Creatinine \> 130 Umol/L Or Creatinine Clearance \< 45 Ml/Min, Aspartate transaminase (AST) \> 2 Times Above The Normal Range, Alanine transaminase (ALT) \> 2 Times Above The Normal Range, Serum Potassium \< 3.5 Or \> 5.5 Meq/L
* Patient with osteoarthritis who has undergone hip or knee replacement within the last 4 months
* Patient with chronic inflammatory conditions such as rheumatoid arthritis, lupus, inflammatory bowel disease and those that need a chronic inflammatory therapy such as prednisone or other steroid agents
* Patient with symptomatic heart failure (classes 3 and 4)
* Patient with a history of stroke within the last 6 months
* Patient with coronary heart disease: has undergone percutaneous coronary angioplasty, has had coronary artery bypass, has had past myocardial infarction, all that occurred less than 6 months prior to visit 1 or has unstable angina
* Patient having participated in an investigational drug program in the last 30 days (prior to Visit 1)
* Unable or unwilling to comply with the protocol, therefore likely to leave the trial before its completion
* Patient intends to move or to vacation away from home during the course of the study which would interfere with the scheduled visits.

Primary outcomes:
measure: Change in Systolic Blood Pressure From Baseline to Week 12
timeFrame: Baseline and Week 12
measure: Change in Diastolic Blood Pressure From Baseline to Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change in Systolic Blood Pressure From Baseline to Week 6
timeFrame: Baseline and Week 6
measure: Change in Diastolic Blood Pressure From Baseline to Week 6
timeFrame: Baseline and Week 6
measure: Number of Patients Achieving Target Blood Pressure at Week 6
timeFrame: Week 6
measure: Number of Patients Achieving Target Blood Pressure at Week 12
timeFrame: 12 Weeks
measure: Time to Achieve Target Blood Pressure
timeFrame: 12 weeks
measure: Change in Uric Acid From Baseline to Week 6
timeFrame: Baseline and Week 6
measure: Change in Uric Acid From Baseline to Week 12
timeFrame: Baseline and Week 12
measure: Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6
timeFrame: Baseline and Week 6
measure: Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12
timeFrame: Baseline and Week 12
measure: Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6
timeFrame: Baseline and Week 6
measure: Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: