Evaluation of Effect of Combination With Telmisartan and Hydrochlorothiazide in Hypertensives Uncontrolled on Amlodipine (ONEAST)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Tokyo University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Tokyo University
Information provided by:
Tokyo University
ClinicalTrials.gov Identifier:
NCT00509470
First received: July 28, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to compare depressor effect and safety between combination therapy with telmisartan plus low-dose hydrochlorothiazide and amlodipine in hypertensive patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Essential Hypertension |
Drug: telmisartan plus hydrochlorothiazide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | ONgoing Evaluation of Depressor Effect And Safety of Combination Therapy With Telmisartan and Low-Dose Hydrochlorothiazide in Patients With Hypertension Uncontrolled on Amlodipine Treatment |
Resource links provided by NLM:
Further study details as provided by Tokyo University:
Primary Outcome Measures:
- Changes in office blood pressure [ Time Frame: After 12 week treatment ]
Secondary Outcome Measures:
- 1) Home blood pressure in early morning and before going to bed 2) Changes in uric acid, total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, fasting plasma glucose (only in diabetic patients), hemoglobin A1c (only in diabetic patients [ Time Frame: After 12 week treatment ]
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | March 2008 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Amlodipine (5 mg/day) is continuously administered. If blood pressure is not reach to lower than 140/90 mmHg, amlodipine can be increased to 7.5 mg/day.
|
Drug: telmisartan plus hydrochlorothiazide
Combination therapy with telmisartan (40 mg/day) plus hydrochlorothiazide (12.5 mg/day): If blood pressure is not reach to lower than 140/90 mmHg, dose of telmisartan can be increased to 80 mg/day
|
Detailed Description:
In hypertensive patients whose blood pressure (BP) does not reach less than 140/90 mmHg with 5mg/day of amlodipine are divided the following two groups and BP response, laboratory data, and adverse effects are compared. Group 1: 12 week combination therapy with telmisartan plus low-dose hydrochlorothiazide. Group 2: Amlodipine is continuously administered.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 5 mg/day of amlodipine is administered for more than 3 months
- Systolic or diastolic blood pressure >= 140/90 mmHg (more than 2 times measurements at outpatient clinic before start of the study)
- Outpatients
Exclusion Criteria:
- Secondary hypertension including renovascular hypertension with single kidney or bilateral stenosis
- Administration of antihypertensives other than amlodipine
- Cardiovascular disease (cerebral hemorrhage, cerebral infarction, TIA, angina, myocardial infarction, acute renal failure) occurs less than 6 months before start of the study
- Serum creatinine >= 2.0 mg/dl
- Severe hypertension (systolic or diastolic blood pressure >= 180/110 mmHg) or malignant hypertension (hypertensive organ damage is rapidly developing)
- Chronic heart failure (NYHA class>=III to VI)
- Contraindication of telmisartan or hydrochlorothiazide
- Hyper- (>= 5.5 mEq/L) or hypo- (<=3.5 mEq/l) potassemia
- Untreated hyperuricemia or uncontrolled hyperuricemia (serum uric acid >= 8.0 mg/dl)
- Diabetic patients who require insulin therapy, uncontrolled diabetic patients (hemoglobin A1c >=9.0%), or patients who possess the risk of hypoglycemic attack
- Patients inadequate for the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00509470
Contacts
| Contact: Katsuyuki Ando, MD, PhD | +81-3-5800-9119 | katsua-tky@umin.ac.jp |
Locations
| Japan | |
| Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine | Recruiting |
| Tokyo, Japan, 113-8655 | |
| Contact: Katsuyuki Ando, MD, PhD +81-3-5800-9119 katsua-tky@umin.ac.jp | |
Sponsors and Collaborators
Tokyo University
Investigators
| Principal Investigator: | Toshiro Fujita, MD, PhD | Professor, Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00509470 History of Changes |
| Other Study ID Numbers: | P2007008 |
| Study First Received: | July 28, 2007 |
| Last Updated: | July 28, 2007 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Amlodipine Telmisartan Benzoates 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 Calcium Channel Blockers Vasodilator Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Antifungal Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 16, 2013