Olmesartan Comparison to Losartan in Hypertensive Subjects

Daiichi Sankyo

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Placebo; Drug: losartan potassium; Drug: olmesartan medoxomil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00949884

CS0866-A-U452

Details and patient eligibility

About

This study will evaluate the efficacy and safety of the FDA approved blood pressure medication olmesartan medoxomil compared to the FDA approved medication losartan potassium.

Enrollment: 941 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females aged > 18 years who are not institutionalized and have signed informed consent.
• Mean cuff seated diastolic blood pressure (BP) must be > 95 mmHg and < 115 mmHg and a mean cuff seated systolic BP must be < 180 mmHg when measured at two consecutive qualification study visits during the placebo run-in phase.
• The difference in mean cuff seated diastolic BP must be < 7 mmHg between two consecutive qualification study visits during the placebo run-in phase.

Exclusion criteria

• Subjects with type 2 diabetes mellitus with an HbA1c ≥ 9.5% at Screening.
• Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of olmesartan medoxomil and losartan potassium, including cardiovascular, renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic (with the exception of non-insulin, dependent type 2 diabetes mellitus with HbA1c < 9.5% at Screening), hematologic/oncologic (including an active malignancy other than basal cell carcinoma), neurologic and psychiatric diseases.
• Subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass surgery or heart failure within the last 12 months.
• Subjects with any history of New York Heart Association Class III or IV congestive heart failure (CHF). A history of New York Heart Association Class I or II CHF may be exclusionary at the discretion of the Investigator.
• Subjects with a history of cerebrovascular accident or transient ischemic attack within the last 1 year.
• Subjects with clinically significant cardiac conduction defects, including second or third degree atrioventricular (AV) block, left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

941 participants in 3 patient groups, including a placebo group

Olmesartan

Experimental group

Description:

Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.

Treatment:

Drug: olmesartan medoxomil

Placebo followed by Olmesartan

Placebo Comparator group

Description:

Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks

Treatment:

Drug: olmesartan medoxomil

Drug: Placebo

Losartan

Active Comparator group

Description:

Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks

Treatment:

Drug: losartan potassium