Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00430508
Recruitment Status : Completed
First Posted : February 2, 2007
Results First Posted : June 17, 2009
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Information provided by:
Daiichi Sankyo, Inc.

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.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets Drug: olmesartan medoxomil/hydrochlorothiazide tablets Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 972 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 4
olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Drug: 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 week

Experimental: 1
olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Drug: olmesartan medoxomil/hydrochlorothiazide tablets
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

Experimental: 3
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
Drug: olmesartan medoxomil/hydrochlorothiazide tablets
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks

Experimental: 2
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Drug: 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 :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430508


  Show 55 Study Locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Investigators
Layout table for investigator information
Study Chair: Professor Lars Christian Rump, M.D. University of Ruhr-Bochum

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bettina Ammentorp, Daichi Sankyo Europe, GmbH
ClinicalTrials.gov Identifier: NCT00430508     History of Changes
Other Study ID Numbers: CS866CM-B-E301
First Posted: February 2, 2007    Key Record Dates
Results First Posted: June 17, 2009
Last Update Posted: January 9, 2019
Last Verified: June 2009
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Keywords provided by Daiichi Sankyo, Inc.:
Moderate-to-Severe Hypertension
Essential Hypertension
Combination Therapy
Fixed-Combination Dose
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Olmesartan
Olmesartan Medoxomil
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists