Clinical trial NCT00949884: Olmesartan Comparison to Losartan in Hypertensive Subjects
Official title: A Randomized, Double-blind, Active-comparator, 8-week Forced-titration Study of the Efficacy and Safety of Olmesartan Medoxomil Versus Losartan Potassium in Hypertensive Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2009-07-30
Enrollment: 941
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
timeFrame: Day 0, Week 8
Secondary outcomes:
measure: Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
timeFrame: Day 0, Week 4
measure: Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
timeFrame: Day 0, Week 8
measure: Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
timeFrame: Day 0, Week 4
Other outcomes:
measure: Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
timeFrame: Week 4, Week 8
measure: Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
timeFrame: Week 4, Week 8
measure: Percentage of Participants Achieving Blood Pressure Goals at Week 4
timeFrame: Week 4
measure: Percentage of Participants Achieving Blood Pressure Goals at Week 8
timeFrame: Week 8
measure: Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline to Week 2 in Trough, Cuff, Seated Blood Pressure
timeFrame: Baseline, Week 2
Locations:
city: Mesa
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Harbor City
country: United States
state: California
city: Tustin
country: United States
state: California
city: Westlake Village
country: United States
state: California
city: Pueblo
country: United States
state: Colorado
city: Deerfield Beach
country: United States
state: Florida
city: DeLand
country: United States
state: Florida
city: South Bend
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Metairie
country: United States
state: Louisiana
city: Albuquerque
country: United States
state: New Mexico
city: Binghamton
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Greenville
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: New Tazewell
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
Study officials:
References:
citation: Punzi HA, Lewin A, Li W, Chavanu KJ. Efficacy/safety of olmesartan medoxomil versus losartan potassium in naive versus previously treated subjects with hypertension. Adv Ther. 2012 Jun;29(6):524-37. doi: 10.1007/s12325-012-0029-5. Epub 2012 Jul 3.