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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007720
Receipt No. R000009097
Scientific Title Metabolic Effect of Combined Telmisartan and Nifedipine CR Therapy in Patients with Essential Hypertension
Date of disclosure of the study information 2012/04/10
Last modified on 2012/04/10

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Basic information
Public title Metabolic Effect of Combined Telmisartan and Nifedipine CR Therapy in Patients with Essential Hypertension
Acronym Metabolic Effect of Combined Telmisartan and Nifedipine CR Therapy in Patients with Essential Hypertension
Scientific Title Metabolic Effect of Combined Telmisartan and Nifedipine CR Therapy in Patients with Essential Hypertension
Scientific Title:Acronym Metabolic Effect of Combined Telmisartan and Nifedipine CR Therapy in Patients with Essential Hypertension
Region
Japan

Condition
Condition Essential Hypertension without metabolic disease
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the metabolic effects of a combination of telmisartan and a long-acting CCB, nifedipine (nifedipine control release; nifedipine CR), in patients with essential hypertension.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Metabolic parameters (lipids, glucose, Homa-IR, leptin and aoponectin)
Key secondary outcomes Blood pressure, heart rate, body weight, and Blood chemistry analysis, neurohormonal parameters (noradrenaline, plasma renin activity, aldosterone)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Outpatients with essential hypertension whose office systolic BP (SBP) was greater than 140 mmHg or whose diastolic BP (DBP) was greater than 90 mmHg on more than 2 different occasions.
All patients were received telmisartan(40mg/day) for 6 weeks.
Patients whose office BP did not reduced to 140/90 mmHg after 6 weeks took nifedipine CR (20-40mg/day) for 18 weeks. Other patients received only telmisartan for 18 weeks.
Key exclusion criteria Patients had diabetes mellitus, hypercholesterolemia, metabolic syndrome or cardiovascular disease and were not taking any anti-hypertensive medicines for at least 6 months.
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumiyasu Yamasaki
Organization Kochi Medical School
Division name Clinical Laboratory
Zip code
Address Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL 088-866-5811
Email

Public contact
Name of contact person
1st name
Middle name
Last name Fumiyasu Yamasaki
Organization Kochi Medical School
Division name Clinical Laboratory
Zip code
Address Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL 088-866-5811
Homepage URL
Email yamasakf-kochimed@umin.net

Sponsor
Institute Kochi Medical School
Institute
Department

Funding Source
Organization Kochi Medical School
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Inoue Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 高知大学医学部(高知県)、井上病院(高知県) (Kochi Medical School(Kochi), Inoue Hospital (Kochi)

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2005 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 07 Month 01 Day
Last follow-up date
2009 Year 08 Month 01 Day
Date of closure to data entry
2009 Year 09 Month 01 Day
Date trial data considered complete
2009 Year 09 Month 01 Day
Date analysis concluded
2009 Year 09 Month 01 Day

Other
Other related information Prospective observational study

Management information
Registered date
2012 Year 04 Month 10 Day
Last modified on
2012 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009097

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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