Safety and Tolerability of Azilsartan Medoxomil Plus Chlorthalidone Compared to Olmesartan Medoxomil Plus Hydrochlorothiazide in Participants With Essential Hypertension
|Essential Hypertension||Drug: Azilsartan medoxomil and chlorthalidone Drug: Olmesartan medoxomil and hydrochlorothiazide||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase 3, Open-Label, Randomized, Long-Term Comparison of the Safety and Tolerability of the TAK-491 Plus Chlorthalidone Fixed-Dose Combination vs. Olmesartan Medoxomil-Hydrochlorothiazide Fixed-Dose Combination in Subjects With Essential Hypertension|
- Percentage of Participants With at Least 1 Adverse Event [ Time Frame: From Week 0 (Day 1) to Week 52. ]An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product without regard to causality.
- Percentage of Participants With Serum Creatinine Elevations Greater Than 50% From Baseline and Greater Than the Upper Limit of Normal (ULN) [ Time Frame: Baseline and Week 52 ]Serum creatinine was measured at every visit and evaluated as a laboratory parameter of special interest. The percentage of participants with creatinine increase ≥50% from Baseline and greater than ULN was summarized: - At any visit (includes transient and persistent elevations). - At the Final Visit (includes persistent elevations and participants whose first elevation may have been at the Final Visit). - At least 2 consecutive visits (includes only persistent elevations).
|Study Start Date:||October 2009|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Experimental: Azilsartan Medoxomil and Chlorthalidone
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks.
For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg.
Drug: Azilsartan medoxomil and chlorthalidone
Other Name: TAK-491CLD
Active Comparator: Olmesartan Medoxomil and Hydrochlorothiazide QD
Participants in the United States:
Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg.
Participants in Europe:
Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg.
Drug: Olmesartan medoxomil and hydrochlorothiazide
High Blood Pressure (Hypertension) is the most common cause of preventable death in developed nations. Uncontrolled hypertension greatly increases the risk of heart disease, brain disease, and kidney failure. As the population ages, the incidence of hypertension will continue to increase if effective preventive measures are not implemented. Despite the availability of antihypertensive agents, hypertension is not adequately controlled; only about one in three patients successfully keep blood pressure normal.
Treatment for high blood pressure includes thiazides or thiazide-like diuretics, either alone or as part of combination treatment. Chlorthalidone is a commercially available, orally administered thiazide-type diuretic agent.
TAK-491 (azilsartan) is an angiotensin II receptor blocker being evaluated by Takeda to treat patients with high blood pressure (essential hypertension).
This study will compare the safety and tolerability of azilsartan medoxomil plus chlorthalidone (TAK-491CLD) fixed-dose combination to olmesartan medoxomil-hydrochlorothiazide fixed-dose combination.
Initially patients will undergo a Screening Visit to confirm that they are eligible to participate in the study. All participants will receive the study drug for up to 52 weeks. The dose of the study drug may be gradually increased throughout the study so that a target blood pressure value can be reached for each participant.
Throughout the treatment period of the study, participants will be required to visit the research site for 11 visits. At these study visits participants will be required to undergo certain study procedures including physical examinations, vital sign measurements (blood pressure, heart rate, weight and height), electrocardiograms (monitoring of the heart), and blood and urine samples taken for clinical laboratory tests.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996281
|Graz, Styria, Austria|
|Karlsruhe, Baden-Wurttemberg, Germany|
|Hannover, Lower Saxony, Germany|
|Kiel-Kronshagen, Schleswig-Holstein, Germany|
|Breda, North Brabant, Netherlands|
|Eindhoven, North Brabant, Netherlands|
|Amsterdam, North Holland, Netherlands|
|Velp, Rheden, Netherlands|
|Leiderdorp, South Holland, Netherlands|
|Zoetermeer, South Holland, Netherlands|
|Rotterdam, Zuid-Holland, Netherlands|
|Bydgoszcz, Kuyavian-Pomeranian, Poland|
|Skierniewice, L0dz, Poland|
|Zgierz, L0dz, Poland|
|Gdansk, Pomeranian, Poland|
|Gdynia, Pomeranian, Poland|
|Sopot, Pomeranian, Poland|
|Mikolow, Silesian, Poland|
|Avon, England, United Kingdom|
|Bolton, England, United Kingdom|
|Chorley, England, United Kingdom|
|Inverness, England, United Kingdom|
|Liverpool, England, United Kingdom|
|Surrey, England, United Kingdom|
|Warwickshire, England, United Kingdom|
|Study Director:||Executive Medical Director, Clinical Science||Takeda|