Clinical Trials List
2012-07-01 - 2013-06-30
Phase III
Terminated10
A 14 week, randomized, double-blind, multi-center, parallel group, active controlled study to evaluate the efficacy and safety of LCZ696 in comparison to olmesartan in elderly patients with essential hypertension
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Shih-Hsien Sung Division of Cardiovascular Diseases
- Wen-Chung Yu Division of Cardiovascular Diseases
- 許百豐 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 葉東峰 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- I-Chang Hsieh Division of Cardiovascular Diseases
- 陳俊吉 Division of Cardiovascular Diseases
- 張尚宏 Division of Cardiovascular Diseases
- 洪國竣 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 蔡青峰 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 黃宏凱 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 方修御 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 陳業鵬 Division of Cardiovascular Diseases
- Chih Hsueh Lin Division of Cardiovascular Diseases
- 盧炯睿 Division of Cardiovascular Diseases
- Po-Yen Ko Division of Cardiovascular Diseases
- 王宇澄 Division of Cardiovascular Diseases
- 謝禮全 Division of Cardiovascular Diseases
- Wen-Yuan Lin Division of Cardiovascular Diseases
- Shih-Sheng Chang Division of Cardiovascular Diseases
- 楊晨佳 Division of Cardiovascular Diseases
- 陳恬恩 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
• Office Blood Pressure
• 24 Hour Ambulatory Blood Pressure
Other assessments:
• Vital signs
• Physical examination
• Hematology, biochemistry, urinalysis
• AEs/SAEs
Inclution Criteria
• Male and female patients, ≥ 65 years of age.
• Patients with essential hypertension, untreated or currently taking
antihypertensive therapy.
• Untreated patients (either newly diagnosed or those patients with a
history of hypertension but have not been taking any antihypertensive
drugs for at least 4 weeks prior to Visit 1) must have an msSBP ≥ 150
mmHg and < 180 mmHg at both Visit 1 and Visit 201.
• Pre-treated patients (using antihypertensive treatments within 4 weeks
prior to Visit 1) must have an msSBP ≥ 150 mmHg and < 180 mmHg at the randomization visit (Visit 201) and msSBP ≥ 140 mmHg < 180 mmHg
at the visit immediately preceding Visit 201 (Visit 102 or 103).
Exclusion Criteria
• Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥
110 mmHg and/or msSBP ≥ 180 mmHg).
• History of angioedema, drug-related or otherwise.
• History or evidence of a secondary form of hypertension, including but not
limited to any of the following: renal parenchymal hypertension, renovascular
hypertension (unilateral or bilateral renal artery stenosis), coarctation of the
aorta, primary hyperaldosteronism, Cushing’s disease, pheochromocytoma,
polycystic kidney disease, and drug-induced hypertension.
• Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1
or any history of stroke.
• History of myocardial infarction, coronary bypass surgery or any
percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
The Estimated Number of Participants
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Taiwan
100 participants
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Global
576 participants
