A Study to Evaluate the Effects of Manidipine Versus Amlo... | NCT00627952

Studies
A Study to Evaluate the Effects of Manidipine Versus Amlodipine and the Combination of Manidipine Plus Delapril Versus Amlodipine Plus Delapril on Intraglomerular Pressure in Hypertensive Patients

NCT00627952

Sponsor

University of Erlangen-Nürnberg Medical School

Status

Completed

Last Update Posted

Jan 21, 2013Estimated

Enrollment

100Actual

Phase

Phase 3

Conditions

Hypertension

Interventions

amlodipine 10 mg
manidipine 20 mg
amlodipine 5 mg + delapril 30 mg
manidipine 10 mg + delapril 30 mg

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
MANTRA

Official Title

Double Blind, Randomized, Parallel Group, Multicentre Study to Evaluate the Effects of Manidipine 20 MG Vs. Amlodipine 10 MG and the Combination of Manidipine 10 MG Plus Delapril 30 MG Vs. Amlodipine 5 MG Plus Delapril 30 MG on Intraglomerular Pressure in Hypertensive Patients

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Feb 24, 2008

First Submission Date that Met QC Criteria

Feb 24, 2008

First Posted Date

Mar 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2013

Last Update Posted Date

Jan 21, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Roland E. Schmieder, Prof. Dr. med., University of Erlangen-Nürnberg Medical SchoolPrincipal Investigator

Lead Sponsor

University of Erlangen-Nürnberg Medical SchoolOTHER

Collaborators

Name	Class
Chiesi Farmaceutici S.p.A.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Eight-week multi-national, multicenter, randomized, double blind, active control, two arms, parallel groups study with a 4-week single drug treatment (manidipine or amlodipine) phase followed by a 4-week combination treatment (manidipine + delapril or amlodipine + delapril) phase.

Detailed Description

The aim of the current study is to assess the effect of a 4-week single drug treatment with manidipine or amlodipine and a 4-week combination treatment with manidipine plus delapril or amlodipine plus delapril on intraglomerular pressure in subjects with hypertension.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
amlodipine 10 mg	Active Comparator		Drug: amlodipine 10 mg Drug: amlodipine 5 mg + delapril 30 mg
manidipine 20 mg	Active Comparator		Drug: manidipine 20 mg Drug: manidipine 10 mg + delapril 30 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
amlodipine 10 mg	Drug	amlodipine 10 mg once daily	amlodipine 10 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
effect of manidipine 20 mg once daily compared to amlodipine 10 mg once daily on intraglomerular pressure		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
effects of combination of manidipine 10 mg plus delapril 30 mg once daily compared with once daily amlodipine 5 mg plus delapril 30 mg on intraglomerular pressure		4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male or female patients aged 18 years or older
mild to moderate hypertension (systolic blood pressure > 139 mmHg or diastolic blood pressure > 89 mmHg)

Exclusion Criteria:

secondary form of arterial hypertension
severe hypertension (systolic blood pressure > 179 mmHg or diastolic blood pressure > 109 mmHg)
pregnant or lactating women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roland E Schmieder, Professor	University of Erlangen-Nürnberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nurnberg		Erlangen	Bavaria	91054	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29268712	Derived	Bosch AJ, Harazny JM, Kistner I, Friedrich S, Wojtkiewicz J, Schmieder RE. Retinal capillary rarefaction in patients with untreated mild-moderate hypertension. BMC Cardiovasc Disord. 2017 Dec 21;17(1):300. doi: 10.1186/s12872-017-0732-x.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds