Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

Phase 3

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: olmesartan medoxomil/hydrochlorothiazide tablets; Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo; Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets

• Registration Number: NCT00430508
• 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: 2008-03
• Study Completion: 2008-05
• Results First Submitted: 2009-02-09
• Results First Submitted QC: 2009-04-29
• Status Verified: 2009-06
• Results First Posted: 2009-06-17
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2019-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 972

Inclusion Criteria

• Male or female Europeans aged 18 years or older with moderate to severe hypertension (HTN)

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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/hydrochlorothiazide tablets	olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
4	olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo	olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
3	olmesartan medoxomil/hydrochlorothiazide tablets	olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
2	olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets	olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

Primary Outcome Measures

Name	Time	Method
Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16	8 weeks, change = week 16 - week 8	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	Change = Week 12 - Week 8 (baseline).
Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.	8 weeks, change = week 16 - week 8	Change = Week 16 - Week 8 (baseline).
Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.	4 weeks, change = week 12 - week 8	Change = Week 12 - Week 8 (baseline).
Number of Patients Achieving Target Blood Pressure at Week 16	8 weeks	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
Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.	8 weeks, change = week 16 - week 8	Change = Week 16 - Week 8 (baseline).
Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.	8 weeks, change = week 16 - week 8	Change = Week 16 - Week 8 (baseline).
Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.	8 weeks, change = week 16 - week 8	Change = Week 16 - Week 8 (baseline).