Clinical Trials List
2015-08-01 - 2018-12-31
Phase II
Terminated12
ICD-10H35
Other retinal disorders
ICD-10I10
Essential (primary) hypertension
Antihypertensive effect of different doses of Rostafuroxin in comparison with Losartan, assessed by office and ambulatory blood pressure monitoring in a hypertensive population selected according to a specific genetic profile.
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Trial Applicant
COVANCE TAIWAN SERVICES LIMITED
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Sponsor
CVie Therapeutics Company Limited.
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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 無
- 吳承學 無
- Tse-Min Lu 無
- Wen-Chung Yu 無
- Tze-Fan Chao 無
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
Audit
None
Co-Principal Investigator
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
1. Systolic Blood Pressure [ Time Frame: Week 9 of treatment versus baseline ]
Automated sitting and standing SBP and DBP will be recorded by physician at baseline (two visits) and at week 2, 5 and 9 of treatement.
sitting: after the patient has rested for at least 10 minutes in a quiet room. There are five consecutive sitting BP readings with a 30 to 60 seconds interval between the readings; the mean of the last three sitting BP will be used.
Secondary Outcome Measures :
1. Diastolic blood pressure [ Time Frame: Baseline (two visits) and then at week 2, 5 and 9 of treatment ]
Diastolic blood pressure measurements will be performed at the same times of the systolic blood pressure measurements, as described above
2. Trough-to-peak ratio on Systolic Blood Pressure [ Time Frame: Throughout 24 hours ABPM ]
Ambulatory Blood Pressure Monitoring (ABPM)will be performed throuhgout 24 hours at baseline and at week 9 of treatement. Readings will be Centralized. The Core Laboratory will be in charge for data interpretation
3. Number of participants with adverse events [ Time Frame: throughout all the study period and follow-up (30 days) ]
All the Adverse Events will be recorded and followed-up till their resolution. Number of Adverse Events in each group treatment will be computed, including single event frequencies and number of patients with adverse events. AEs will be collected on spontaneous reporting by patients and a number of standard safety procedure: i.e. recording of ECGs, standard blood chemistry and haematology, performed before, during and at the end of the treatment period.
Inclution Criteria
Signature of a written informed consent, included informed consent on
genotype analysis.
Male/female patient aged 25-60 years.
Naive hypertensive patient (new diagnosed patient, never treated before
or, if treated up to 7 days, after 1 month of washout).
Documented mild to moderate arterial hypertension, as defined below:
o At Visits 1 and 2 the mean of the last 3 consecutive readings of
SBP must be 140 mmHg and DBP must be 85 mmHg, when
measured by Clinic (OBP);
o At Visit 3, the mean of the last 3 consecutive readings of SBP
must be 140 mmHg 169 mmHg and DBP must be
85 mmHg and ≤ 100 mmHg, when measured by Clinic
(OBP).
Presence of at least one mutated genotype or combination of genotypes
corresponding to the list provided in Genetic Profile 1.
Exclusion Criteria
Known causes of secondary hypertension;
Severe or malignant hypertension;
History of renal artery disease;
Significant renal or hepatic disease ;
Cardiac disease requiring prohibited pharmacological treatment or history
of myocardial infarction within the last 6 months;
Atrial Fibrillation;
Complete Left and/or Right Ventricle Bundle Branch Block;
First degree AV-block exceeding 240 msec;
Electrocardiographic evidence of left ventricular hypertrophy;
Pregnant or nursing women or women of childbearing potential not taking
anti-contraceptive medication or not utilizing a double contraceptive
method;
Surgery or disease of the gastrointestinal tract, which might influence
absorption or elimination of the drug;
Any concomitant condition that may, in the judgement of the Investigator,
jeopardise participant adherence to the Protocol or ability to complete the
trial;
Concomitant therapy with medications that may affect blood pressure;
Treatment with any investigational drug in the previous 6 months;
Predictable lack of cooperation;
Obesity 30 kg/m2;
Diabetes mellitus;
Statines treatment.
The Estimated Number of Participants
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Taiwan
120 participants
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Global
280 participants
