A Phase-3 Randomized, Double-Blind, Efficacy and Safety Study Evaluating the Fixed Dose Combinations of TAK-491 Plus Chlorthalidone (40/12.5 mg and 40/25 mg) in Subjects With Grades 2 or 3 Essential Hypertension, Who Do Not Achieve Target Blood Pressure Following Treatment With TAK-491 40 mg Monotherapy.

A Phase-3 Randomized, Double-Blind, Efficacy and Safety Study Evaluating the Fixed Dose Combinations of TAK-491 Plus Chlorthalidone (40/12.5 mg and 40/25 mg) in Subjects With Grades 2 or 3 Essential Hypertension, Who Do Not Achieve Target Blood Pressure Following Treatment With TAK-491 40 mg Monotherapy. - TAKEDA TAK-491CLD_307

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35852

Enrollment

Registered

2011-06-10

Start date

2011-09-26

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Grades 2 or 3 Hypertension/High blood pressure

Interventions

Taking investigational product.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • The subject has grade 2-3 essential hypertension which is not adequately controlled as defined by mean, trough, sitting, clinic SBP: >=160 to =150 to =140 to =140 mm Hg as determined by the mean of 3 sitting, trough, measurements) following 4 weeks single-blind treatment with TAK-491 40 mg monotherapy at Day -1, prior to randomization to double-blind treatment.

Exclusion criteria

Exclusion criteria: • The subject has clinic DBP >110 mm Hg. • The subject*s 3 SBP measurements at screening differ by more than 15 mm Hg (confirmed by a second set of three measurements). • The subject is currently treated with more than 2 antihypertensive medications. • The subject has secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushing*s syndrome). •The subject has any history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, persistent or permanent atrial fibrillation or transient ischemic attack. • The subject has clinically significant cardiac conduction defects (eg, third-degree atrioventricular block, sick sinus syndrome). • The subject has severe renal dysfunction or disease [based on estimated glomerular filtration rate (eGFR) 8.5%) at Screening

Design outcomes

Primary

Measure	Time frame
Change from baseline to Week 8 in trough, sitting, clinic SBP.	—

Secondary

Measure	Time frame
* Change from baseline to Week 8 in trough, sitting, clinic DBP. * Change from baseline to Week 8 in trough (22 to 24 hours after dosing) SBP as measured by ABPM. * Change from baseline to Week 8 in trough DBP as measured by ABPM. * Change from baseline to week 8 in the following ABPM parameters: - 24-hour mean SBP and DBP. - Mean daytime (6 AM to 10 PM) SBP and DBP. - Mean nighttime (12 AM to 6 AM) SBP and DBP. - Mean SBP and DBP at 0 to 12 hours after dosing. * Proportion of subjects who achieve target blood pressure at Week 8 as defined by the following: a) Trough, sitting clinic SBP	—

Measure

Time frame

* Change from baseline to Week 8 in trough, sitting, clinic DBP. * Change from baseline to Week 8 in trough (22 to 24 hours after dosing) SBP as measured by ABPM. * Change from baseline to Week 8 in trough DBP as measured by ABPM. * Change from baseline to week 8 in the following ABPM parameters: - 24-hour mean SBP and DBP. - Mean daytime (6 AM to 10 PM) SBP and DBP. - Mean nighttime (12 AM to 6 AM) SBP and DBP. - Mean SBP and DBP at 0 to 12 hours after dosing. * Proportion of subjects who achieve target blood pressure at Week 8 as defined by the following: a) Trough, sitting clinic SBP

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)