---
title: Efficacy and Safety of Carvedilol SR Versus Carvedilol IR in Patients With Essential Hypertension
nct_id: NCT01756430
overall_status: COMPLETED
phase: PHASE3
sponsor: Chong Kun Dang Pharmaceutical
study_type: INTERVENTIONAL
primary_condition: Hypertension
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01756430.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01756430"
ct_last_update_post_date: 2014-01-14
last_seen_at: "2026-05-12T06:31:11.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT01756430](https://clinicaltrials.gov/study/NCT01756430)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 238
- **Lead Sponsor:** Chong Kun Dang Pharmaceutical
- **Conditions:** Hypertension
- **Start Date:** 2012-12
- **Completion Date:** 2013-09
- **CT.gov Last Update:** 2014-01-14

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Carvedilol SR 32mg, 64mg** (EXPERIMENTAL) — •Carvedilol SR 32mg QD for first 4 weeks and Carvedilol SR 64mg QD for following 4 weeks.
- **Carvedilol IR 25mg** (ACTIVE_COMPARATOR) — •Carvedilol IR 25mg QD for first 4 weeks and Carvedilol IR 25mg BID for following 4 weeks.

## Interventions

- **Carvedilol SR 32mg, QD** (DRUG) — * Carvedilol SR 32mg QD for 4 weeks
* With the others investigation product placebo 1 capsule QD and 1 tablet BID for 4 weeks.
- **Carvedilol SR 64mg, QD** (DRUG) — * Carvedilol SR 64mg QD for 4 weeks
* With the others investigation product placebo 1 capsule QD and 1 tablet BID for 4 weeks.
- **Carvedilol IR 25mg, QD** (DRUG) — * Carvedilol IR 25mg QD for 4 weeks
* With the others investigation product placebo 2 capsules and 1 tablet QD for 4 weeks.
- **Carvedilol IR 25mg, BID** (DRUG) — * Carvedilol IR 25mg BID for 4 weeks
* With the others investigation product placebo 2 capsules QD for 4 weeks.

## Primary Outcomes

- **Mean Sitting Diastolic Blood Pressure (MSDBP)** _(time frame: After 4 and 8 weeks of treatment)_

## Secondary Outcomes

- **Mean Sitting systolic Blood Pressure (MSSBP)** _(time frame: After 4 weeks and 8 weeks of treatment)_
- **Control Rate** _(time frame: After 8 weeks of treatment)_
- **Response Rate** _(time frame: After 8 weeks of treatment)_

## Locations (1)

- The Hanyang Universitiy Guri Hospital, Guri-si, Gyeonggi-do, South Korea

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the hanyang universitiy guri hospital|guri-si|gyeonggi-do|south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01756430.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01756430*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*