Olmesartan in Essential Hypertension
This study has been completed.
Sponsor:
Sankyo Pharma Gmbh
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00185172
First received: September 12, 2005
Last updated: April 28, 2008
Last verified: April 2008
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Purpose
To test the efficacy and safety of olmesartan in patients with essential hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Essential Hypertension |
Other: placebo Drug: olmesartan medoxomil Drug: olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of Olmesartan: Reduction of Blood Pressure in the Treatment of Patients Suffering From Mild to Moderate Essential Hypertension |
Resource links provided by NLM:
Further study details as provided by Daiichi Sankyo Inc.:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- To detect less frequent adverse drug reactions and assess the safety and tolerability of olmesartan. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 2333 |
| Study Start Date: | January 2002 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
2 week placebo run-in
|
Other: placebo
Placebo oral tablets for 2 weeks
|
|
Experimental: 2
Olmesartan medoxomil tablets for 8 weeks
|
Drug: olmesartan medoxomil
olmesartan medoxomil oral tablets for 8 weeks
|
|
Experimental: 3
Olmesartan medoxomil tablets, or olmesartan medoxomil tablets + hydrochlorothiazide tablets for 4 weeks
|
Drug: olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets
olmesartan medoxomil oral tablets,or olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185172
Locations
| Austria | |
| Result Cro | |
| Wien, Austria, 1130 | |
| Germany | |
| INPUT GmbG | |
| Aachen, Germany, 52074 | |
| Italy | |
| Biokos Farma s.r.l. | |
| Bologna, Italy, 40122 | |
| Netherlands | |
| IMRO TRAMARKO International bv | |
| Berghem, Netherlands, 5352 | |
| Portugal | |
| EUROTRIALS Lda | |
| Lisboa, Portugal, 1070-274 | |
| Spain | |
| Phidea S.L. | |
| Madrid, Spain, 28002 | |
| Switzerland | |
| PFC Pharma Focus Consultants AG | |
| Zurich, Volketswil, Switzerland, 8604 | |
| United Kingdom | |
| Inveresk Ltd. | |
| Edinburgh, United Kingdom | |
Sponsors and Collaborators
Sankyo Pharma Gmbh
Investigators
| Principal Investigator: | Prof. Michael Bohm, MD | Universitatskliniken des Saarlandes, Homburg, Germany |
More Information
No publications provided
| Responsible Party: | Senior Manager Study Coordinator, Daiichi Sankyo Europe, GmbH |
| ClinicalTrials.gov Identifier: | NCT00185172 History of Changes |
| Other Study ID Numbers: | SP-OLM-01-00 |
| Study First Received: | September 12, 2005 |
| Last Updated: | April 28, 2008 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Olmesartan medoxomil Olmesartan Diuretics Natriuretic Agents Physiological Effects of Drugs |
Pharmacologic Actions Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
ClinicalTrials.gov processed this record on May 22, 2013