Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

Daiichi Sankyo972 enrolled

Overview

The study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high blood pressure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

972

Conditions

Essential Hypertension

Interventions

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placeboDRUG

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 week

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tabletsDRUG

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

olmesartan medoxomil/hydrochlorothiazide tabletsDRUG

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female Europeans aged 18 years or older with moderate to severe hypertension (HTN) Exclusion Criteria: * Female patients of childbearing potential pregnant, lactating or planning to become pregnant during the trial period. * Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the study medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases. * Patients having a history of the following within the last six months: * myocardial infarction, * unstable angina pectoris, * percutaneous coronary intervention, * severe heart failure, * hypertensive encephalopathy, * cerebrovascular accident (stroke) or * transient ischaemic attack. * Patients with clinically significant abnormal laboratory values at screening. * Patients with secondary HTN.

Locations (55)

Outcomes

Primary Outcomes

Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16

Change = Week 16 - Week 8 (baseline).

Time frame: 8 weeks, change = week 16 - week 8

Secondary Outcomes

Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12.

Change = Week 12 - Week 8 (baseline).

Time frame: 4 weeks, change = week 12 - week 8

Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.

Change = Week 16 - Week 8 (baseline).

Time frame: 8 weeks, change = week 16 - week 8

Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.

Change = Week 12 - Week 8 (baseline).

Time frame: 4 weeks, change = week 12 - week 8

Number of Patients Achieving Target Blood Pressure at Week 16

Target Blood Pressure is diastolic blood pressure (dBP) \< 90 mmHg and systolic blood pressure (sBP) \< 140 mmHg for non-diabetics, and dBP \< 80 mmHg and sBP \< 130 mmHg for diabetics

Time frame: 8 weeks

Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.

Change = Week 16 - Week 8 (baseline).

Time frame: 8 weeks, change = week 16 - week 8

Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.

Change = Week 16 - Week 8 (baseline).

Data from ClinicalTrials.gov

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Unnamed facility

Pleven, Bulgaria

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Sofia, Bulgaria

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Beroun, Czechia

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Brno, Czechia

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Chrudim, Czechia

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Hradec Králové, Czechia

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Jindřichův Hradec, Czechia

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Kutná Hora, Czechia

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Ostrava, Czechia

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Pardubice, Czechia

...and 45 more locations