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Olmesartan Comparison to Losartan in Hypertensive Subjects

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00949884
First received: July 29, 2009
Last updated: March 7, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
 Drug: olmesartan medoxomil
Drug: Placebo
Drug: losartan potassium
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) [ Time Frame: Day 0, Week 8 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) [ Time Frame: Day 0, Week 4 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) [ Time Frame: Day 0, Week 8 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) [ Time Frame: Day 0, Week 4 ] [ Designated as safety issue: No ]
    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.


Enrollment: 941
Study Start Date: August 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • olmesartan medoxomil
  • Benicar
  • Olmetec
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:
  • olmesartan medoxomil
  • Benicar
  • Olmetec
Drug: Placebo
placebo oral tablets once daily for two weeks
Other Name: placebo
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
  • Losartan potassium

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949884

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

No publications provided by Daiichi Sankyo Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Director, Medical Affairs, Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00949884     History of Changes
Other Study ID Numbers: CS0866-A-U452
Study First Received: July 29, 2009
Results First Received: January 31, 2011
Last Updated: March 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Losartan
Olmesartan medoxomil
Olmesartan
Anti-Arrhythmia Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013