Clinical Trials List
Protocol NumberCLCZ696A2222
2012-09-01 - 2013-12-31
Phase II
Terminated4
A randomized, double-blind, crossover study to assess the effects of LCZ696 and valsartan in Asian patients with salt-sensitive hypertension.
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
NOVARTIS
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Tse-Min Lu Division of Cardiovascular Diseases
- 林幸榮 教研部
- Kang-Ling Wang Division of Cardiovascular Diseases
- Wen-Chung Yu Division of Cardiovascular Diseases
- Shih-Hsien Sung 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
- 黃惠君 Division of Cardiovascular Diseases
- CHIEN-HUA HUANG Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 謝禮全 Division of Cardiovascular Diseases
- 王宇澄 Division of Cardiovascular Diseases
- 楊晨佳 Division of Cardiovascular Diseases
- Wen-Yuan Lin Division of Cardiovascular Diseases
- Shih-Sheng Chang Division of Cardiovascular Diseases
- Po-Yen Ko Division of Cardiovascular Diseases
- Chih Hsueh Lin Division of Cardiovascular Diseases
- 盧炯睿 Division of Cardiovascular Diseases
- 陳業鵬 Division of Cardiovascular Diseases
- 陳恬恩 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
hypertension
Objectives
This exploratory profiling study is designed to provide mechanistic data in support of the LCZ696 development program for the treatment of hypertension in Asia and therefore aims at evaluating the effect of LCZ696 and valsartan on natriuresis, diuresis, and blood pressure in salt-sensitive Asian hypertensive patients.
Test Drug
LCZ696
Active Ingredient
LCZ696
Dosage Form
tablets
Dosage
400mg/ tab
Endpoints
Pharmacodynamic assessments:
- Natriuresis and Diuresis
- 24 hour ABPM Blood pressure
Safety assessments:
- Physical examination
- Vital signs, including serial supine BP and pulse measurements.
- Laboratory evaluations (hematology, blood chemistry, urinalysis)
- Electrocardiogram (ECG)
- Natriuresis and Diuresis
- 24 hour ABPM Blood pressure
Safety assessments:
- Physical examination
- Vital signs, including serial supine BP and pulse measurements.
- Laboratory evaluations (hematology, blood chemistry, urinalysis)
- Electrocardiogram (ECG)
Inclution Criteria
Inclusion criteria:
(1) Written informed consent must be obtained before any study assessment is performed.
(2) Males and females of non-childbearing potential and of legal age (at least 18 years or older as defined by local law).
(3) Asian patients with mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy with up to two drugs.
(1) Written informed consent must be obtained before any study assessment is performed.
(2) Males and females of non-childbearing potential and of legal age (at least 18 years or older as defined by local law).
(3) Asian patients with mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy with up to two drugs.
Exclusion Criteria
Exclusion criteria:
(1) Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer; or longer if required by local regulations.
(2) Women of child-bearing potential (WOCBP).
(3)Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
(4) History of angioedema, drug-related or otherwise.
(5) History of hypersensitivity to LCZ696, valsartan, or drugs of similar chemical classes.
(6) Severe hypertension (grade 3 of WHO classification) at screening or at the end of the washout period.
(7) History or evidence of a secondary form of hypertension.
(8) Concomitant use of any anti-hypertensives or diuretics or drug with effects on diuresis, natriuresis or blood pressure for the duration of the study.
(10) Transient ischemic cerebral attack (TIA) during the 12 months prior to screening or any history of stroke.
(11) History of myocardial infarction, coronary bypass surgery or percutaneous coronary intervention (PCI) during 12 month prior to screening.
(12) . Current angina pectoris requiring any pharmacological therapy, including but not limited to oral or topical nitrates.
(13) Current or history of hypertensive retinopathy.
(14) History of syncope or documented symptomatic hypotension.
(15) Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled based on the investigator’s clinical judgment.
(16) Previous or current diagnosis of heart failure (NYHA Class II-IV).
(17) Clinically significant valvular heart disease at screening.
(18) History or current diagnosis of the following cardiac abnormalities.
(19) History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.
(20) Any concomitant disease that could potentially pose a risk to a patient during the study.
(21) Use of herbal supplements, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) during the study period starting with treatment washout.
(1) Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer; or longer if required by local regulations.
(2) Women of child-bearing potential (WOCBP).
(3)Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
(4) History of angioedema, drug-related or otherwise.
(5) History of hypersensitivity to LCZ696, valsartan, or drugs of similar chemical classes.
(6) Severe hypertension (grade 3 of WHO classification) at screening or at the end of the washout period.
(7) History or evidence of a secondary form of hypertension.
(8) Concomitant use of any anti-hypertensives or diuretics or drug with effects on diuresis, natriuresis or blood pressure for the duration of the study.
(10) Transient ischemic cerebral attack (TIA) during the 12 months prior to screening or any history of stroke.
(11) History of myocardial infarction, coronary bypass surgery or percutaneous coronary intervention (PCI) during 12 month prior to screening.
(12) . Current angina pectoris requiring any pharmacological therapy, including but not limited to oral or topical nitrates.
(13) Current or history of hypertensive retinopathy.
(14) History of syncope or documented symptomatic hypotension.
(15) Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled based on the investigator’s clinical judgment.
(16) Previous or current diagnosis of heart failure (NYHA Class II-IV).
(17) Clinically significant valvular heart disease at screening.
(18) History or current diagnosis of the following cardiac abnormalities.
(19) History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.
(20) Any concomitant disease that could potentially pose a risk to a patient during the study.
(21) Use of herbal supplements, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) during the study period starting with treatment washout.
The Estimated Number of Participants
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Taiwan
12 participants
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Global
70 participants
