Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

Phase 3

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets; Drug: olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg

• Registration Number: NCT00430950
• Lead Sponsor: Daiichi Sankyo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-01
• Study First Submitted QC: 2007-02-01
• Study First Posted: 2007-02-02
• Primary Completion: 2008-05
• Study Completion: 2008-10
• Results First Submitted: 2009-02-09
• Results First Submitted QC: 2009-03-13
• Results First Posted: 2009-04-20
• Status Verified: 2017-10
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1011

Inclusion Criteria

• Male or female Europeans aged 18 years or older with moderate to severe HTN, defined as follows (conventional BP measurements)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets	olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ) 40/25 mg + OM/HCTZ 20/25 mg matching placebo
2	olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg	olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ)20/25 mg + OM/HCTZ 40/25 matching placebo

Primary Outcome Measures

Name	Time	Method
Change in Mean Trough Sitting Diastolic Blood Pressure	8 weeks	Change in mean trough sitting diastolic Blood Pressure between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline.; Change = Week 16 - Week 8 (baseline).

Secondary Outcome Measures

Name	Time	Method
Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12	4 weeks	Change = Week 12 - Week 8 (baseline).
Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.	8 weeks	4 weeks Change = Week 12 - Week 8 (baseline). 8 weeks Change = Week 16 - Week 8 (baseline).
Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.	8 weeks	Change = Week 16 - Week 8 (baseline).
Number of Participants Achieving Blood Pressure Goal.	8 weeks