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| Sponsor: | Seoul National University Hospital |
|---|---|
| Information provided by: | Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT00533858 |
Purpose
The aim of this study is to evaluate the effect of lacidipine and losartan in elderly hypertensive patients on reducing the 24 hour systolic BP variability, which is one of the potential parameter to consider in treating elderly hypertensive patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: lacidipine (4 mg) or losartan (50 mg) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Estimated Enrollment: | 160 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | September 2008 |
In this study, we investigate the effects of two anti-hypertensive medications on systolic BP variability profile as a pilot study. This is a prospective, randomized, open-label, blinded end point (PROBE), parallel group study with two treatment arms. At the end of an initial 2-week washout period, during which any eventual anti-hypertensive drug is discontinued, patients fulfilling the inclusion criteria are randomly treated with the lacidipine (4 mg) or losartan (50 mg), both given once daily at the same hour in the morning (approximately at 8 AM) for 12 weeks. If the BP goal (SBP < 140 mmHg and DBP < 90 mmHg) has not been attained after 4 week's treatment, 12.5 mg hydrochlorothiazide (HCTS) once daily can be added.
Patients are checked 24-h ambulatory BP monitoring (ABPM) at the end of the washout period and after 12 weeks of active treatment. At each visit, seated cuff SBP and DBP, heart rate, use of concomitant medication and spontaneously reported adverse events are recorded.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Cheol-Ho Kim, MD, PhD | 82-31-787-7001 | cheolkim@snu.ac.kr |
| Korea, Republic of | |
| Seoul National University Bundang Hospital | Recruiting |
| Seongnam, Kyeonggi, Korea, Republic of, 463-707 | |
| Contact: Cheol-Ho Kim, MD, PhD 82-31-787-7001 cheolkim@snu.ac.kr | |
| Principal Investigator: | Cheol-Ho Kim, MD, PhD | Seoul National University Bundang Hospital |
More Information
| ClinicalTrials.gov Identifier: | NCT00533858 History of Changes |
| Other Study ID Numbers: | 06-2007-083 |
| Study First Received: | September 21, 2007 |
| Last Updated: | October 18, 2008 |
| Health Authority: | Korea: Food and Drug Administration |
|
Systolic hypertension |
|
Hypertension Vascular Diseases Cardiovascular Diseases Lacidipine Losartan Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Anti-Arrhythmia Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |