UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007720 |
|---|---|
| Receipt number | 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 15:20:43 |
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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
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
yamasakf-kochimed@umin.net
Sponsor or person
Institute
Kochi Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009097
