Olmesartan Comparison to Losartan in Hypertensive Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: olmesartan medoxomil; Drug: Placebo; Drug: losartan potassium

• Study Type: Interventional
• Enrollment (Actual): 941
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85213
    • Phoenix, Arizona, United States, 85050
  • California
    • Harbor City, California, United States, 90710
    • Tustin, California, United States, 92780
    • Westlake Village, California, United States, 91361
  • Colorado
    • Pueblo, Colorado, United States, 81001
  • Florida
    • DeLand, Florida, United States, 32720
    • Deerfield Beach, Florida, United States, 33442
  • Indiana
    • South Bend, Indiana, United States, 46614
  • Kansas
    • Wichita, Kansas, United States, 67205
  • Louisiana
    • Metairie, Louisiana, United States, 70006
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
  • New York
    • Binghamton, New York, United States, 13701
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
  • Ohio
    • Cincinnati, Ohio, United States, 45219
  • South Carolina
    • Greenville, South Carolina, United States, 29615
  • Tennessee
    • Bristol, Tennessee, United States, 37620
    • New Tazewell, Tennessee, United States, 37825
  • Texas
    • Dallas, Texas, United States, 75230
  • Virginia
    • Norfolk, Virginia, United States, 23502

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Olmesartan; Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.	Drug: olmesartan medoxomil; Oral tablets, once daily, at either 20mg or 40mg daily.; Other Names: Olmetec; Benicar
Placebo Comparator: Placebo followed by Olmesartan; 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	Drug: olmesartan medoxomil; Oral tablets, once daily, at either 20mg or 40mg daily.; Other Names: Olmetec; Benicar; Drug: Placebo; placebo oral tablets once daily for two weeks
Active Comparator: Losartan; Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks	Drug: losartan potassium; losartan potassium oral tablet at either 50mg or 100 mg daily dose.; Other Names: Cozaar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)	The change from baseline in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.	Day 0, Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)	The change from baseline in trough SSBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.	Day 0, Week 4
Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)	The change from baseline in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.	Day 0, Week 8
Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)	The change from baseline in trough SDBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.	Day 0, Week 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)	The change from Week 4 in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.	Week 4, Week 8
Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)	The change from Week 4 in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.	Week 4, Week 8
Percentage of Participants Achieving Blood Pressure Goals at Week 4	Percentage of participants who achieved the following goals: Systolic blood pressure: <140 mmHg, <135 mmHg, <130 mmHg, <120 mmHg Diastolic blood pressure: <90 mmHg, <85 mmHg, <80 mmHg Blood pressure: <140/90 mmHg, <135/80 mmHg, <130/80 mmHg	Week 4
Percentage of Participants Achieving Blood Pressure Goals at Week 8	Percentage of participants who achieved the following goals: Systolic blood pressure: <140 mmHg, <135 mmHg, <130 mmHg, <120 mmHg Diastolic blood pressure: <90 mmHg, <85 mmHg, <80 mmHg Blood pressure: <140/90 mmHg, <135/80 mmHg, <130/80 mmHg, <120/80 mmHg	Week 8
Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4	In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours.	Baseline, Week 4
Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8	In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours.	Baseline, Week 8
Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4	In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized.	Baseline, Week 4
Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8	In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized.	Baseline, Week 8
Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4	In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized.	Baseline, Week 4
Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8	In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized.	Baseline, Week 8
Change From Baseline to Week 2 in Trough, Cuff, Seated Blood Pressure	The change from baseline in trough systolic and diastolic blood pressure at Week 2 as measured by the Omron monitor. Morning doses of study medication were taken after the exam, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.	Baseline, Week 2

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: July 29, 2009
• First Submitted That Met QC Criteria: July 29, 2009
• First Posted (Estimate): July 30, 2009

Study Record Updates

• Last Update Posted (Estimate): March 9, 2011
• Last Update Submitted That Met QC Criteria: March 7, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Losartan; Olmesartan; Olmesartan Medoxomil
• Other Study ID Numbers: CS0866-A-U452