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Completed

NCT Number: NCT00430508

Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pleven, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets

Drug

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

olmesartan medoxomil/hydrochlorothiazide tablets

Drug

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

Primary outcomes

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

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

    Change = Week 16 - Week 8 (baseline).

Secondary outcomes

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

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

    Change = Week 12 - Week 8 (baseline).

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

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

    Change = Week 16 - Week 8 (baseline).

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

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

    Change = Week 12 - Week 8 (baseline).

  4. Number of Patients Achieving Target Blood Pressure at Week 16

    Time frame: 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

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

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

    Change = Week 16 - Week 8 (baseline).

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

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

    Change = Week 16 - Week 8 (baseline).

  7. Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.

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

    Change = Week 16 - Week 8 (baseline).

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Collaborators

  • Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Registry information

Official study title

Efficacy and Safety of Hydrochlorothiazide (HCTZ) Used as Add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil (OM) 40 mg Monotherapy

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 2, 2007
Registry last updated
Jan 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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