Effectiveness of Losartan 50 mg/HCTZ 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg Titrated as Needed in Patients With Hypertension Not Controlled on Monotherapy

Condition(s) targeted: Hypertension

Intervention: hydrochlorothiazide (+) losartan potassium (Drug); Comparator: Valsartan (+) Hydrochlorothiazide (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

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

Official title: 12-Week, Open-Label, Randomized, Controlled Trial Comparing the Effectiveness of Losartan 50 mg/HCTZ 12.5 mg Versus Valsartan 80 mg/HCTz 12.5 mg in  Hypertensives Not Controlled on Monotherapy

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Primary outcome: Mean change reduction in SBP and DBP during 12 weeks of treatment with losartan 50 mg/HCTZ 12.5 mg titrated as needed versus valsartan 80 mg/HCTZ 12.5 mg titrated as needed

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- An adult patient between > 18 and 75 years of age 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 BP > 140/90 mmHg up to 160/100 mmHg (inclusive)

- either systolic or diastolic BP > 130/80 mmHg up to 150/90 mmHg (inclusive) for

diabetic patients

- Patient is male or a female who is highly unlikely to conceive

Exclusion Criteria:

- Patient needing a initiation of a lipid lowering agent or a modification of his lipid

therapy at visit 1 or during the study period (12 weeks)

- 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, AST >  2 times above the normal range, 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 or with chronic inflammatory conditions such as rheumatoid arthritis, lupus, inflammatory bowel disease and those that needs a chronic inflammatory therapy such as prednisone or other steroid agents

- Patient with symptomatic heart failure (classes 3 and 4), with a history of stroke

within the last 6 months, coronary heart disease: has undergone percutaneous coronary angioplasty, has had coronary artery bypass, has had past myocardial infarction or has angina

(MedWatch - FDA maintained medical product safety Information)

(PhRMA Clinical Study Results Database - web-based repository for clinical study results)

(Merck: Patient & Caregiver U.S. Product Web Site)

Starting date: May 2007
Ending date: December 2007
Last updated: January 4, 2008