NCT02177461

Brief Summary

Study to assess the efficacy and tolerability of Telmisartan 40-80 mg once daily compared with enalapril 10-20 mg once daily in elderly patients with arterial hypertension.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
374

participants targeted

Target at P75+ for phase_4 hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
11.9 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

2.3 years

First QC Date

June 26, 2014

Last Update Submit

July 7, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in 24-hours mean systolic blood pressure (SBP) (ABPM - ambulatory blood pressure measurement, 24 hours mean represents the average of 24 hourly mean values)

    Baseline and week 8

Secondary Outcomes (7)

  • Comparison of SBP ABPM tracing profile

    Week 8 and 24

  • Changes from baseline in trough cuff (sphygmomanometer) SBP

    Baseline, week 8 and 24

  • Smoothness index in comparison with baseline

    Baseline, week 8 and 24

  • Number of responders

    Week 8 and 24

  • Number of controlled responders

    Week 8 and 24

  • +2 more secondary outcomes

Study Arms (4)

Telmisartan

EXPERIMENTAL
Drug: Telmisartan

Enalapril

ACTIVE COMPARATOR
Drug: Enalapril

Telmisartan + clonidine TTS1

EXPERIMENTAL
Drug: TelmisartanDrug: Clonidine

Enalapril + clonidine TTS1

ACTIVE COMPARATOR
Drug: EnalaprilDrug: Clonidine

Interventions

TelmisartanDRUG
TelmisartanTelmisartan + clonidine TTS1
EnalaprilDRUG
EnalaprilEnalapril + clonidine TTS1
ClonidineDRUG
Enalapril + clonidine TTS1Telmisartan + clonidine TTS1

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age ≥ 65 years
  • Sitting systolic blood pressure (SBP) ≥ 160 mmHg and any diastolic blood pressure (DBP) (safety maximum of sitting DBP 110 mmHg), measured by manual cuff sphygmomanometer at the end of the wash-out period
  • Written informed consent

You may not qualify if:

  • Secondary hypertension
  • Malignant hypertension (retinal haemorrhage, exudates or papillary oedema)
  • Clinically significant sodium depletion as defined by serum sodium level \< 130 mEq/L, clinically significant hyperkaliemia as defined by serum potassium level \> 5.5 mEq/L, clinically significant hypokaliemia as defined by serum potassium level \< 3.0 mEq/L
  • Atrial fibrillation or frequent ventricular ectopic beats or other arrhythmias which could interfere with the cardiac rhythm
  • Heart rate \< 50 bpm
  • Congestive heart failure (CHF) (NYHA (New York Heart Association) functional class CHF III-IV)
  • Angina pectoris or myocardial infarction
  • Cardiac surgery within the past 3 months prior to start the wash-out period
  • Stroke within the past 6 months prior to start the wash-out period
  • Renal insufficiency defined as creatininaemia \> 2mg/dl
  • Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post renal transplant
  • Liver insufficiency, defined as bilirubinaemia \> 2mg/dl and AST (aspartate aminotransferase) or ALT (alanine-aminotransferase) \> twice the upper normal range
  • Clinically significant metabolic and endocrine disease
  • Autoimmune disease
  • Previous history of angioedema
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

TelmisartanEnalaprilClonidine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2014

First Posted

June 27, 2014

Study Start

April 1, 2000

Primary Completion

August 1, 2002

Last Updated

July 8, 2014

Record last verified: 2014-07