| September 8, 2005 |
| October 11, 2007 |
| August 2003 |
| |
| Change in mean sitting diastolic blood pressure (dBP), assessed by conventional BP measurements after 12 weeks of treatment |
| Same as current |
| Complete list of historical versions of study NCT00151827 on ClinicalTrials.gov Archive Site |
- - Change in mean sitting dBP, assessed by conventional BP measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment;
- - Change in mean sitting sBP, assessed by conventional BP measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment;
- - Response to treatment (i.e. mean sitting dBP less than or equal to 90 mmHg or reduction greater than or equal to 10 mmHg) after 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks of treatment;
- - Changes in CLcr and serum creatinine after 12 and 52 weeks of treatment, changes in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment;
- - Onset of BP lowering effect;
- - Rate of patients per dose level after 12 and 52 weeks of treatment;
- - Safety and tolerability.
|
- - Change in mean sitting dBP, assessed by conventional BP
- measurements
- - Change in mean sitting sBP, assessed by conventional BP
- - Response to treatment (i.e. mean sitting dBP less than
- or equal to 90 mmHg or reduction greater than or equal to
- 10 mmHg)
- - Changes in CLcr and serum creatinine after 12 and 52
- weeks of treatment, changes in proteinuria
- - Onset of BP lowering effect
- - Safety and tolerability
|
| |
| Olmesartan Medoxomil in Hypertension and Renal Impairment |
| Efficacy and Safety of Olmesartan Medoxomil Compared With Losartan in Patients With Hypertension and Mild to Moderate Renal Impairment |
This is a study in hypertensive patients with mild to moderate renal impairment. The antihypertensive efficacy of olmesartan medoxomil is compared to losartan. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
- Essential Hypertension
- Renal Impairment
|
- Drug: Olmesartan medoxomil
- Drug: Losartan
- Drug: Furosemide
|
| |
| |
| |
| Completed |
| 400 |
| February 2006 |
|
Inclusion Criteria:
- Mean sitting BP prior to randomization of 140-180/90-109 mmHg;
- Renal impairment prior to randomization of mild (50 ≤ CLcr ≥ 80 mL/min) to moderate (30 ≤ CLcr ≥50 mL/min) severity
Exclusion Criteria:
- Malignant hypertension or sitting BP greater than 180/109 mmHg;
- Severe heart failure, severe renal disease;
- Recent history of myocardial infarction, stroke or transient ischemic attack;
- History, clinical or current evidence of any significant gastrointestinal, respiratory, hematological, metabolic, immunological or any other underlying disease which in the opinion of the investigator would interfere with the patient's participation in the trial;
- Hypersensitivity or contraindications to ARBs or ACE inhibitors or any cross allergy;
- Treatment with dis-allowed medication;
- Pregnant or breastfeeding females or females of childbearing potential without adequate contraception;
- History of drug and/or alcohol abuse
|
| Both |
| 18 Years to 75 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Germany |
| |
| NCT00151827 |
|
| SE-866/43 |
| Sankyo Pharma Gmbh |
|
| Principal Investigator: |
P. U. Witte, MD, PhD |
IMFORM GmbH, Darmstadt, Germany |
|
|
| Daiichi Sankyo Inc. |
| October 2007 |