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Olmesartan in Essential Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00185172
First Posted: September 16, 2005
Last Update Posted: April 29, 2008
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.
Information provided by:
Daiichi Sankyo, Inc.
September 12, 2005
September 16, 2005
April 29, 2008
January 2002
June 2005   (Final data collection date for primary outcome measure)
To compare the efficacy on diastolic blood pressure of 40 mg olmesartan to a combination of 20 mg olmesartan and 12.5 mg hydrochlorothiazide in patients who are not sufficiently responding to treatment with 20 mg olmesartan. [ Time Frame: From week 8 to week 12 ]
To compare the efficacy on diastolic blood pressure of olmesartan to a combination of olmesartan and hydrochlorothiazide in patients who are not sufficiently responding to treatment with olmesartan alone
Complete list of historical versions of study NCT00185172 on ClinicalTrials.gov Archive Site
  • To assess the effects on systolic and diastolic blood pressure of 20 mg olmesartan, 40 mg olmesartan and the combination of 20 mg olmesartan with 12.5 mg hydrochlorothiazide at week 2, 4, 8 and 12. [ Time Frame: 12 weeks ]
  • To detect less frequent adverse drug reactions and assess the safety and tolerability of olmesartan. [ Time Frame: 12 weeks ]
  • To assess the effects on systolic and diastolic blood pressure of olmesartan, and the combination of olmesartan with hydrochlorothiazide.
  • Safety and tolerability.
Not Provided
Not Provided
 
Olmesartan in Essential Hypertension
Efficacy and Safety of Olmesartan: Reduction of Blood Pressure in the Treatment of Patients Suffering From Mild to Moderate Essential Hypertension
To test the efficacy and safety of olmesartan in patients with essential hypertension.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Essential Hypertension
  • Other: placebo
    Placebo oral tablets for 2 weeks
  • Drug: olmesartan medoxomil
    olmesartan medoxomil oral tablets for 8 weeks
  • Drug: olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets
    olmesartan medoxomil oral tablets,or olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets
  • Placebo Comparator: 1
    2 week placebo run-in
    Intervention: Other: placebo
  • Experimental: 2
    Olmesartan medoxomil tablets for 8 weeks
    Intervention: Drug: olmesartan medoxomil
  • Experimental: 3
    Olmesartan medoxomil tablets, or olmesartan medoxomil tablets + hydrochlorothiazide tablets for 4 weeks
    Intervention: Drug: olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2333
June 2005
June 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age: 18 (19 if required by local authorities) to 75 years
  • Males and females of any race. Female participants must take adequate contraceptive measures (oral contraceptives, I.U.D.), be post-menopausal or surgically sterilized
  • Essential hypertension: sitting DBP greater than or equal to 90 and less than 110 mmHg
  • Written Informed Consent
  • Mentally competent
  • Negative pregnancy test in women at a childbearing age at the beginning of the study

Exclusion Criteria:

  • Patients with known severe (World Health Organization (WHO) stage III, sitting DBP stable at greater than or equal to 110 mmHg), malignant or secondary hypertension
  • Patients who have had a myocardial infarction or percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within the last 6 months
  • Patients with a history or current evidence of congestive heart failure
  • Bilateral renal artery stenosis
  • Severe renal insufficiency (serum creatinine greater than 200 micro mol/l)
  • Severe hepatic impairment or biliary obstruction
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Italy,   Netherlands,   Portugal,   Spain,   Switzerland,   United Kingdom
 
 
NCT00185172
SP-OLM-01-00
No
Not Provided
Not Provided
Senior Manager Study Coordinator, Daiichi Sankyo Europe, GmbH
Sankyo Pharma Gmbh
Not Provided
Principal Investigator: Prof. Michael Bohm, MD Universitatskliniken des Saarlandes, Homburg, Germany
Daiichi Sankyo, Inc.
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP