Efficacy and Safety of CKD-828 to Stage 2 Hypertension

NCT01634295 | Completed Phase 3

• 1 other identifier: 130HT11P
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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, 2.5/80mg and 5/80mg) compared with S-Amlodipine monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension.

Conditions

Hypertension

Keywords

CKD-828; Hypertension; Stage 2 Hypertension; S-Amlodipine; Telmisartan

Outcome Measures

Primary Outcomes (1)

• Mean Sitting systolic Blood Pressure (MSSBP)

  After 10 weeks of treatment

Secondary Outcomes (4)

• Mean Sitting systolic Blood Pressure (MSSBP)

  After 2 weeks, 4 weeks and 6 weeks of treatment

• Mean Sitting diastolic Blood Pressure (MSDBP)

  After 2weeks, 4weeks, 6weeks and 10 weeks of treatment

• Control Rate

  After 10 weeks of treatment

• Response Rate

  After 10 weeks of treatment

Study Arms (2)

CKD-828 2.5/40, 2.5/80, 5/80mg

EXPERIMENTAL

Drug: CKD-828 2.5/40mg; Drug: CKD-828 5/40mg; Drug: CKD-828 5/80mg

S-Amlodipine 2.5, 5mg

ACTIVE COMPARATOR

Drug: S-amlodipine 2.5mg; Drug: S-amlodipine 5mg

Interventions

CKD-828 2.5/40mg DRUG

* Fixed dose combination of S-amlodipine 2.5mg and Telmisartan 40mg QD 2 weeks. * With the others investigation product placebo 4 tabs QD 2 weeks.

Also known as: CKD-828

CKD-828 2.5/40, 2.5/80, 5/80mg

CKD-828 5/40mg DRUG

* Fixed dose combination of S-amlodipine 5mg and Telmisartan 40mg QD 2 weeks. * With the others investigation product placebo 4 tabs QD 2 weeks.

Also known as: CKD-828

CKD-828 2.5/40, 2.5/80, 5/80mg

CKD-828 5/80mg DRUG

* Fixed dose combination of S-amlodipine 5mg and Telmisartan 80mg QD 6 weeks. * With the others investigation product placebo 4 tabs QD 6 weeks.

Also known as: CKD-828

CKD-828 2.5/40, 2.5/80, 5/80mg

S-amlodipine 2.5mg DRUG

* S-amlodipine 2.5mg QD 4 weeks * With the others investigation product placebo 4 tabs QD 4 weeks.

Also known as: Anydipine S

S-Amlodipine 2.5, 5mg

S-amlodipine 5mg DRUG

* S-amlodipine 2.5mg QD 6weeks * With the others investigation product placebo 4 tabs QD 6 weeks.

Also known as: Anydipine S

S-Amlodipine 2.5, 5mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 years or older
• at the screening visit
• antihypertensive drugs not taking: 160mmHg ≤ sitSBP \< 200mmHg
• antihypertensive drugs taking: 140mmHg ≤ sitSBP \< 180mmHg
• at the randomization visit(160mmHg ≤ sitSBP \< 200mmHg)
• willing and able to provide written informed consent

You may not qualify if:

• mean sitting DBP ≥ 120mmHg or mean sitting SBP ≥ 200mmHg at the screening visit and randomization visit
• for the past four weeks based on beginning of administration, patients took over four antihypertensive drugs
• 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), ischaemic heart diseasesstatus need to treatment, myocardiopathy, Valve disease, arrhythmia and so on and operated Coronary angioplasty
• 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
• defined by the following laboratory parameters:
• hepatic dysfunction(AST/ALT \> UNL X 3)
• renal dysfunction(serum creatinine \> UNL X 1.5)
• hypopotassemia(K \< 3.0mmol/L) or hyperpotassemia (K\>5.5 mmol/L)
• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Seoul national university Bundang Hospital

Bundang-gu, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

levamlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tae-hoon An, Ph.D

  Gachon University Gil Medical Center

  PRINCIPAL INVESTIGATOR

• Eun-joo Jo, Ph.D

  The Catholic university of Korea St. Paul's Hospitial

  PRINCIPAL INVESTIGATOR

• Jong-jin Kim, Ph.D

  Kyung Hee university Hosipital at Gangdong

  PRINCIPAL INVESTIGATOR

• Jang-ho Bae, Ph.D

  Konyang University Hosipital

  PRINCIPAL INVESTIGATOR

• Chang-kyu Park, Ph.D

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

• Young-dae Kim, Ph.D

  Dong-A University

  PRINCIPAL INVESTIGATOR

• Chul-ho Kim, Ph.D

  Seoul National University Bundang Hospital

  STUDY CHAIR

• Sae-Joong Lim, Ph.D

  Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

• Uk-Bum Phyun, Ph.D

  Ewha Women University Mokdong Hospital

  PRINCIPAL INVESTIGATOR

• Gyu-Rok Han, Ph.D

  Kangdong Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

• Sang Hyun Kim, Ph.D

  Seoul National University Boramae Hospital

  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: July 3, 2012
• First Posted: July 6, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 21, 2013

Record last verified: 2013-06

Locations

KR (1)