CKD-828 Primary Hypertension Trial(Dose-selection)

NCT01128322 | Completed Phase 2

• 1 other identifier: 128HT09K
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 26

Brief Summary

The aim of this trial is to determine the best dose combination of S-Amlodipine and Telmisartan as compared to monotherapy by assessing the blood pressure lowering effects of a once daily regimen of various combinations of S-Amlodipine and Telmisartan, compared to their monotherapy components and placebo, in patients with stage I or II essential hypertension(a mean seated cuff diastolic blood pressure \>=95 and \<=115 mmHg).

Conditions

Hypertension

Keywords

CKD-828; Hypertension; Primary Hypertension; S-Amlodipine; Telmisartan; Amlodipine; Factorial; Phase 2

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

• Response rate

  After 4 weeks and 8 weeks of treatment

• Control rate

  After 4 weeks and 8 weeks of treatment

Study Arms (9)

S-Amlodipine 2.5mg + Telmisartan 40mg

EXPERIMENTAL

Drug: S-Amlodipine, Telmisartan

S-Amlodipine 2.5mg + Telmisartan 80mg

EXPERIMENTAL

Drug: S-Amlodipine, Telmisartan

S-Amlodipine 5mg + Telmisartan 40mg

EXPERIMENTAL

Drug: S-Amlodipine, Telmisartan

S-Amlodipine 5mg + Telmisartan 80mg

EXPERIMENTAL

Drug: S-Amlodipine, Telmisartan

S-Amlodipine 2.5mg

ACTIVE COMPARATOR

Drug: S-Amlodipine

S-Amlodipine 5mg

ACTIVE COMPARATOR

Drug: S-Amlodipine

Telmisartan 40mg

ACTIVE COMPARATOR

Drug: Telmisartan

Telmisartan 80mg

ACTIVE COMPARATOR

Drug: Telmisartan

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

S-Amlodipine, Telmisartan DRUG

S-Amlodipine 2.5mg + Telmisartan 40mg; S-Amlodipine 2.5mg + Telmisartan 80mg; S-Amlodipine 5mg + Telmisartan 40mg; S-Amlodipine 5mg + Telmisartan 80mg

S-Amlodipine DRUG

S-Amlodipine 2.5mg; S-Amlodipine 5mg

Telmisartan DRUG

Telmisartan 40mg; Telmisartan 80mg

Placebo DRUG

Placebo

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
• stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure \>=95 and \<=115 mmHg
• ability to provide written informed consent

You may not qualify if:

• severe hypertension defined as: a mean seated cuff diastolic blood pressure \>=116mmHg or a mean seated cuff systolic blood pressure \>=200mmHg
• 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 Diabets 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
• 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, currently active gatritis, ulcers of gastrointetinal/rectal bleeding, impaired pancreatic fuction such as pancreatitis,obstructions of the urinary tract or difficulty in voiding)
• cannot swallow investigational products

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (26)

Hallym University Sacred Heart Hospital

Anyang, South Korea

Location

Soonchunhyang University Hospital in Bucheon

Bucheon-si, South Korea

Location

Kosin University Gospel Hospital

Busan, South Korea

Location

Chungbuk National Uiversity Hospital

Cheongju-si, South Korea

Location

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

DonGuk University International Hospital

Goyang, South Korea

Location

National Health Insurance Corporation Ilsan Hospital

Goyang, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Gachon University Gil Medical Center

Inchon, South Korea

Location

Chonbuk National University Hospital

Jeonju, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Ewha Womans University Hospital

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Kandong Sacred Heart Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Kyung Hee University Medical Center

Seoul, South Korea

Location

Seoul St. Mary's Hospital, The catholic University of Korea

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

Soon Chun Hyang University Hospital

Seoul, South Korea

Location

St. Paul's Hospital, The catholic University of Korea

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Uijeongbu St. Mary's Hospital, The catholic University of Korea

Uijeongbu-si, South Korea

Location

Wonju Christian Hospital

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Interventions

levamlodipine; Telmisartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 21, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 26, 2011

Record last verified: 2011-04

Locations

KR (26)