N/A
Completed N=529
The Effects on Blood Pressure Control, Pulse Wave Velocity, as Well as Safety and Tolerability of Felodipine Sustained Release in Chinese Patients.
Source: ClinicalTrials.gov NCT02336607 ↗Enrolled (actual)
529
Serious AEs
0.4%
Results posted
Mar 2015
Primary outcomePrimary: The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 14 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. — 74.1; 80.5; 80.2; NA Percentage
Summary
The purpose of this study is to evaluate the effects on blood pressure control, pulse wave velocity, as well as safety and tolerability of felodipine single or combine with other drugs in Chinese Hypertension patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 14 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. |
74.1; 80.5; 80.2; NA | — |
| SECONDARY The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. |
45.8; 59.5; 46.2; NA | — |
| SECONDARY The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. |
78.6; 79; 78.7; NA | — |
| SECONDARY The Magnitude of Systolic and Diastolic Blood Pressure Change From Baseline Among All Randomized Subjects After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. |
-10.3; -13.4; -9.8; NA; -7.3; -9.9 | — |
| SECONDARY The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. |
-17.8; -18.0; -16.4; NA; -11.3; -12.1 | — |
| SECONDARY The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. |
-16.6; -18.0; -16.8; NA; -10.7; -12.8 | — |
| SECONDARY The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. |
-16.1; -17.1; -16.4; NA; -12.3; -10.9 | — |
| SECONDARY The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. |
-19.4; -19.7; -18.5; NA; -13.4; -13.1 | — |
| SECONDARY The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. |
-18.4; -20.3; -18.2; NA; -13.0; -13.6 | — |
| SECONDARY The Change of Pulse Wave Velocity at 12 Weeks Compare With Baseline Data of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. |
-0.12; -0.44; -0.06; NA | — |
| SECONDARY The Change of Pulse Wave Velocity From Baseline at 2, 14 Weeks of Felodipine Sustained Release Alone. |
NA; NA; NA; -0.58; NA; NA | — |
| SECONDARY The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 2 Weeks of Felodipine Sustained Release, Alone |
NA; NA; NA; -22.8; NA; NA | — |
Eligibility Criteria
Inclusion Criteria
- Provision of written informed consent
- Female or male aged between 35-79 years old
- Mild to moderate essential hypertension patients who meet any of the following criterias:
- Newly diagnosed, drug-naive, or without any antihypertension treatment for at least 3 months, moderate essential hypertension patients. (160mmHg mean SiSBP 180mmHg or 100mmHg mean SiDBP 110mmHg)
- Newly diagnosed, drug-naive, or without any antihypertension treatment for at least 3 months, mild essential hypertension patients (140mmHg mean SiSBP 160mmHg or 90mmHg mean SiDBP 100mmHg) with high or extreme high cardiovascular risk (a)(having 3 or more than 3 risk factors and/or target organ lesion and/or diabetes mellitus).
(a) according to Chinese guideline for prevention and treatment of patients with hypertension 2004.
- The patients have already received starting dosage of single anti-hypertension drug therapy (exclude the drugs containing felodipine component ), however the blood pressure is not well controlled (140mmHg mean SiSBP 160mmHg or 90mmHg mean SiDBP 100mmHg). After stopping the drug for 5 eliminating half life time, the patients meet any one of the following two:
- 160mmHg mean SiSBP 180mmHg or 100mmHg mean SiDBP 110mmHg.
- 140mmHg mean SiSBP 160mmHg or 90mmHg mean SiDBP 100mmHg) with high or extreme high cardiovascular risk* (having 3 or more than 3 risk factors and/or target organ lesion and/or diabetes mellitus).
Sitting blood pressure is taken after subjects take a seat to rest for 5 minutes before the next medication.
Exclusion Criteria
Any of the following is regarded as a criterion for exclusion from the study:
- Known or suspected secondary hypertension
- Resting heart rate is 0.24seconds), or second or third degree
- Other clinical significant arrhythmia
- Unstable and/or decompensated congestive heart failure
- Angina, acute myocardial infarction, percutaneous coronary intervention (PCI), or cardiac surgery
- Asthma or moderate to severe chronic obstructive pulmonary disease
- Type 1 diabetes mellitus
- Gout history
- Fasting serum glucose of greater than 200 mg/dl (11.1 mmol/L) or type 2 diabetes mellitus needs insulin therapy
- ALT>3ULN
- Cr>1.5mg/dl
- Pregnancy or lactation.
- Alcohol or drug abuse
- Known need for other concomitant anti-hypertensive therapy during the study besides the study drug.
- Known or suspected allergy to investigational drug or non-active ingredients of investigational drugs, known allergy to other blockers, calcium antagonist, diuretics, angiotensin converting enzyme inhibitor or with other contraindications.
- Suspected white-coat hypertension based on investigator's judgement.
Data sourced from ClinicalTrials.gov (NCT02336607). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.