Clinical trial NCT01756430: Efficacy and Safety of Carvedilol SR Versus Carvedilol IR in Patients With Essential Hypertension
Official title: A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of Carvedilol SR Versus Carvedilol IR in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Carvedilol SR
Carvedilol IR
Hypertension
Essential Hypertension
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2012-12-27
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of present study is to evaluate the efficacy and safety of Carvedilol SR versus Carvedilol IR in Patients With Essential Hypertension

Detailed description: * In patients with Essential hypertension to evaluate the efficacy and safety of Carvedilol SR (32mg, 64mg) or Carvedilol IR (25mg QD, 25mg BID) during 8 weeks.
* This study is consist of placebo run-in period(2\~4 weeks_single blind) and treatment period(8 weeks_double blind).

Eligibility criteria: Inclusion Criteria:

* age 18 years or older
* at the screening visit(visit 1)

  * antihypertensive drugs not taking: 90mmHg ≤ mean sitDBP ≤ 109mmHg and mean sitSBP \< 180mmHg
  * antihypertensive drugs taking: mean sitDBP ≤ 104mmHg and mean sitSBP \< 180mmHg
* at the randomization visit(visit 2): 90mmHg ≤ mean sitDBP ≤ 109mmHg and mean sitSBP \< 180mmHg
* willing and able to provide written informed consent

Exclusion Criteria:

1. At Screening, difference in measured blood pressure of the selected arm(sitDBP ≥ 10mmHg or sitSBP ≥ 20mmHg)
2. known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
3. Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c \> 9%)
4. Corresponding to the following

   * has severe heart disease(Heart failure NYHA functional class 3, 4)
   * ischaemic heart diseases within 6 months (unstable angina or myocardial infarction)
   * myocardiopathy
   * Cor pulmonale
   * aortic stenosis , aortic valvular stenosis , mitral stenosis
   * abnormality of the conduction system as 2nd degree AV block, Complete AV block, Sick Sinus Syndrome, Sinus Block(In particular, pulse \<50beats / min)
   * has heart attack with complication.
5. has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
6. has edema glottitis, allergic rhinitis, Respiratory diseases as Asthma, Chronic Obstructive Pulmonary Disease.
7. Peripheral circulatory disturbance( ex. Raynaud syndrome, intermittent claudication)
8. Fluid retention or overload to required intravenous inotropes.
9. known severe or malignant retinopathy(retinal hemorrhage, visual disturbance, Retinal microaneurysms and so on within 6 months)
10. defined by the following laboratory parameters:

    * hepatic dysfunction(AST/ALT ≥ UNL X 3)
    * renal dysfunction(serum creatinine ≥ UNL X 2)
11. any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bypass, active inflammatory bowel syndrome within 12 months prior to screening, gastric ulcers need to treatment, gastrointestinal/rectal bleeding, impaired pancreatic function such as pancreatitis, obstructions of the urinary tract or difficulty in voiding)
12. history of drug or alcohol dependency within 6 months
13. premenopausal women(last menstruation \< 12 months) not using adequate contraception, pregnant or breast-feeding
14. chronic inflammatory status need to treatment
15. known hypersensitivity related to carvedilol
16. history of malignancy including leukemia and lymphoma within the past 5 years
17. administration of other study drugs within 28 days prior to the first IP administration
18. in investigator's judgment

Primary outcomes:
measure: Mean Sitting Diastolic Blood Pressure (MSDBP)
timeFrame: After 4 and 8 weeks of treatment
Secondary outcomes:
measure: Mean Sitting systolic Blood Pressure (MSSBP)
timeFrame: After 4 weeks and 8 weeks of treatment
measure: Control Rate
timeFrame: After 8 weeks of treatment
measure: Response Rate
timeFrame: After 8 weeks of treatment
Other outcomes:
Locations:
city: Guri-si
country: Korea, Republic of
facility: The Hanyang Universitiy Guri Hospital
state: Gyeonggi-do
Study officials:
affiliation: The Hanyang Universitiy Guri Hospital
name: Soon Kill Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea Bucheon St.Mary's Hospital
name: Sang-Hyun Ihm
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea, Seoul St. Vincent's Hospital
name: Sang Hong Haek
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyunghee University Medical Center
name: Jin-Bae Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: National Health Insurance Service Ilsan Hospital
name: Dong Woon Jeon
role: PRINCIPAL_INVESTIGATOR
affiliation: Keimyung University, Donsan Hospital
name: Chang-Wook Nam
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: Dong-Ju Choi
role: PRINCIPAL_INVESTIGATOR
affiliation: Soon Chun Hyang University Hospital
name: Min Su Hyon
role: PRINCIPAL_INVESTIGATOR
affiliation: Sejong General Hospital
name: Young Jin Choi
role: PRINCIPAL_INVESTIGATOR
affiliation: Gangnam Severance Hospital
name: Hyuck Moon Kwon
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hospital
name: Geu Ru Hong
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonju Severance Christian Hospital
name: Byung-Su Yoo
role: PRINCIPAL_INVESTIGATOR
affiliation: Jesus hospital
name: Ji-Hyun Lim
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Young Keun Ahn
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang University Seoul Hospital
name: Jin Ho Shin
role: PRINCIPAL_INVESTIGATOR
References: