NCT01501253

Brief Summary

The aim of present study is to evaluate the efficacy and safety of two dose combination of S-Amlodipine/Telmisartan (2.5/40mg amd 2.5/80mg) compared with S-Amlodipine monotherapy (2.5mg) in hypertensive patients inadequately controlled by S-Amlodipine monotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 29, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

November 14, 2012

Status Verified

November 1, 2012

Enrollment Period

1.1 years

First QC Date

December 26, 2011

Last Update Submit

November 12, 2012

Conditions

Hypertension

Keywords

CKD-828HypertensionPrimary HypertensionS-AmlodipineTelmisartanNon-Responder

Outcome Measures

Primary Outcomes (1)

  • Mean Sitting Diastolic Blood Pressure (MSDBP)

    After 8 weeks of treatment

Secondary Outcomes (4)

  • Mean Sitting Diastolic Blood Pressure (MSDBP)

    After 4 weeks of treatment

  • Mean Sitting Systolic Blood Pressure (MSSBP)

    After 4 weeks and 8 weeks of treatment

  • Control Rate

    After 8 weeks of treatment

  • Response Rate

    After 8 weeks of treatment

Study Arms (3)

CKD-828 2.5/40mg

EXPERIMENTAL

CKD-828 2.5/40mg

Drug: CKD-828 2.5/40mg

CKD-828 2.5/80mg

EXPERIMENTAL

CKD-828 2.5/80mg

Drug: CKD-828 2.5/80mg

S-Amlodipine 2.5mg

ACTIVE COMPARATOR

S-Amlodipine 2.5mg

Drug: S-Amlodipine 2.5mg

Interventions

CKD-828 2.5/40mgDRUG

fixed dose combination of S-Amlodipine 2.5mg and Telmisartan 40mg

CKD-828 2.5/40mg
CKD-828 2.5/80mgDRUG

Fixed dose combination of S-Amlodipine 2.5 and Telmisartan 80mg

CKD-828 2.5/80mg
S-Amlodipine 2.5mgDRUG

S-Amlodipine 2.5mg monotherapy

Also known as: Anydipine S tab.
S-Amlodipine 2.5mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 years or older
  • diagnosis of essential hypertension and blood pressure not adequately controlled (inadequate control defined as seated diastolic blood pressure(DBP)≥ 90mmHg if on existing amtihypertensive treatment of seated DBP≥100mmHg if treatment naive)
  • failure to respond to four weeks treatment with S-Amlodipine 2.5mg(failure to respond defined as seated DBP ≥ 90mmHg)
  • willing and able to provide written informed consent

You may not qualify if:

  • mean seated DBP ≥ 120mmHg and/or mean seated SBP ≥ 200mmHg during run-in treatment or mean seated DBP ≥ 120mmHg and/or mean seated SBP ≥ 180mmHg at the randomization visit
  • known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
  • has severe heart disease(Heart failure NYHA functional class 3, 4), unstable angina or myocardial infarction, arrhythmia within the past three months
  • has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
  • Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) \> 8%
  • known severe or malignant retinopathy
  • hepatic or renal dysfunction as defined by the following laboratory parameters: AST/ALT \> UNL X 2, serum creatinine \> UNL X 1.5
  • acute or chronic inflammatory status need to treatment
  • need to additional antihypertensive drugs during the study
  • need to concomitant medications known to affect blood pressure during the study
  • history of angioedema related to ACE inhibitors or Angiotensin II Receptor Blockers
  • known hypersensitivity related to either study drug
  • history of drug or alcohol dependency within 6 months
  • 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
  • administration of other study drugs within 30 days prior to randomization
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's hospital, The catholic university of Korea

Seoul, South Korea

Location

MeSH Terms

Conditions

HypertensionEssential Hypertension

Interventions

levamlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Ho-Joong Yoon, Ph.D

    Seoul St. Mary's hospital, The catholic university of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2011

First Posted

December 29, 2011

Study Start

August 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

November 14, 2012

Record last verified: 2012-11

Locations

KR(1)