| September 12, 2005 |
| April 28, 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 ] [ Designated as safety issue: No ] |
| 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 ] [ 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 ]
|
- To assess the effects on systolic and diastolic blood pressure of olmesartan, and the combination of olmesartan with hydrochlorothiazide.
- Safety and tolerability.
|
| |
| 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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Essential Hypertension |
- Other: placebo
- Drug: olmesartan medoxomil
- Drug: olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets
|
- Placebo Comparator: 2 week placebo run-in
- Experimental: Olmesartan medoxomil tablets for 8 weeks
- Experimental: Olmesartan medoxomil tablets, or olmesartan medoxomil tablets + hydrochlorothiazide tablets for 4 weeks
|
| |
| |
| 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
|
| Both |
| 18 Years to 75 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Austria, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom |
| |
| NCT00185172 |
| Senior Manager Study Coordinator, Daiichi Sankyo Europe, GmbH |
| SP-OLM-01-00 |
| Sankyo Pharma Gmbh |
|
| Principal Investigator: |
Prof. Michael Bohm, MD |
Universitatskliniken des Saarlandes, Homburg, Germany |
|
|
| Daiichi Sankyo Inc. |
| April 2008 |
