Effect of Caldine® on Renal Function in Balanced Hyperten... | NCT02240641

Studies
Effect of Caldine® on Renal Function in Balanced Hypertension

NCT02240641

Sponsor

Boehringer Ingelheim

Status

Terminated

Last Update Posted

Sep 16, 2014Estimated

Enrollment

5,417Actual

Phase

Not provided

Conditions

Hypertension

Interventions

Lacidipine
Diuretics
antihypertensive drugs
alpha blockers
Angiotensin-Converting Enzyme Inhibitors
beta blockers

Countries

Not provided

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1998

Primary Completion Date

Sep 2000Actual

Completion Date

Not provided

First Submitted Date

Aug 28, 2014

First Submission Date that Met QC Criteria

Sep 15, 2014

First Posted Date

Sep 16, 2014Estimated

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

Sep 15, 2014

Last Update Posted Date

Sep 16, 2014Estimated

Description Module

Brief Summary

The study aimed at comparing the evolution of renal function in patients showing a hypertension treated by various therapeutic strategies.

Due to the contract research organisation (CRO) decision in September 2000, the database was locked and not accessible for Boehringer Ingelheim France. Consequently it was decided to stop the study and not proceed to the analysis. Thus, only safety data were processed in the safety database.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,417Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hypertension treatment strategies			Drug: Lacidipine Drug: Diuretics Drug: antihypertensive drugs Drug: alpha blockers Drug: Angiotensin-Converting Enzyme Inhibitors Drug: beta blockers

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lacidipine	Drug		hypertension treatment strategies	Caldine
Diuretics

Measure	Description	Time Frame
Number of patients with adverse events		up to two years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with hypertension requiring treatment

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with hypertension requiring treatment

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C060285	lacidipine
D004232	Diuretics
D000959	Antihypertensive Agents
D000317	Adrenergic alpha-Antagonists
D000806	Angiotensin-Converting Enzyme Inhibitors
D000319	Adrenergic beta-Antagonists

Ancestor Terms

ID	Term
D045283	Natriuretic Agents
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided