Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets; Drug: olmesartan medoxomil/hydrochlorothiazide tablets; Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00430508

CS866CM-B-E301

Details and patient eligibility

About

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.

Enrollment: 972 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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972 participants in 4 patient groups

4

Experimental group

Description:

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

Treatment:

Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo

1

Experimental group

Description:

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

Treatment:

Drug: olmesartan medoxomil/hydrochlorothiazide tablets

Drug: olmesartan medoxomil/hydrochlorothiazide tablets

3

Experimental group

Description:

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

Treatment:

Drug: olmesartan medoxomil/hydrochlorothiazide tablets

Drug: olmesartan medoxomil/hydrochlorothiazide tablets

2

Experimental group

Description:

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

Treatment:

Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets