Description
This document provides general principles for the clinical evaluation of new anti- hypertensive drugs. It describes core principles for the evaluation of antihypertensives that are accepted in the three ICH regions, but some region-specific differences remain. These differences may be harmonized in future, but it is important at present to refer to existing regional guidelines and to discuss the specific requirements with regional regulatory authorities, if required.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
2pediatric populations are on average less sensitive to these drugs
Specific category of antihypertensive products; products containing two or more antihypertensive agents
Stakeholders
4body to contact regarding research participant rights
A member of the clinical study population from whom data are being collected
responsible for designing and executing the study
entities to consult regarding fixed combination data requirements
Regulatory Context
Regulatory Activities
1Process for assessing new antihypertensive drugs; the overall process of assessing new antihypertensive drugs
Document Types
1template provided for research study participation
Attributes
2Accurate dose-response information is important for maximizing desirable effects.
The randomly assigned dose in a dose-response study
Technical Details
Substances
2Accountability procedures for the investigational product including placebo; used as a reference in a clinical trial
Alternative control for clinical study designs
Testing Methods
7using multiple doses of each component to show contribution; Comparing A plus B to A and to B at their highest approved doses
Recommended Use of ABPM (Ambulatory Blood Pressure Monitoring); Abbreviation for ambulatory blood pressure monitoring
used at the end of treatment to establish assay sensitivity
Short-term study design for clinical evaluation
Study design based on response vs. Placebo
Study design vs. Placebo to reach maintenance dose
Study design to evaluate dose-response relationship
Processes
1characterization of hemodynamic, renal, and neurohumoral effects
Clinical Concepts
7Primary basis of assessment of efficacy; primary measurement for evaluating drug effect
Primary basis of assessment of efficacy
Significant and remediable risk factor
the primary condition for the study population
safety concern regarding excessive fall in blood pressure on standing
secondary condition that limits inclusion in placebo-controlled trials
Appendix detailing clinical trial structures
Identified Hazards
Hazards
1potential detrimental effect requiring outcome studies
Standards & References
Specifications
2evaluation of blood pressure control late in the dose interval
This stock can be used to determine the relative assay sensitivity for detecting RCR.
ICH References (10)
Principles for Clinical Evaluation of New Antihypertensive Drugs
Regulatory standards for the extent of population exposure for treatments intended for long-term treatment
document remedial actions in the clinical trial report; Structure and Content of Clinical Study Reports standards.
Dose-Response Information to Support Drug Registration
Ethnic Factors in the Accessibility of Foreign Clinical Data.
Referenced for safety data collection and adverse event reporting plans.
Studies in Support of Special Populations: Geriatrics
General Considerations for Clinical Studies
Statistical Principles for Clinical Trials; Discourages deterministic procedures due to high risk of bias; Notes that the use of Bayesian methods in clinical trials may be considered.
Choice of Control Group in Clinical Trials.
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- DSCSA Implementation: Product Tracing Requirements — Compliance Policy
- E6(R3) Good Clinical Practice: Annex 2
- Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry: Guidance for Industry
- Best Practices for Communication Between IND Sponsors and FDA During Drug Development
- Botanical Drug Development: Guidance for Industry
- Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
- Reformulating Drug Products That Contain Carbomers Manufactured With Benzene
- ANDA Submissions -- Refuse-to-Receive Standards Rev.2