Brief Summary

Multicenter, prospective, randomised, open study comparing the effect of the following two strategies in hypertensive subjects \> 55 years and poorly controlled (systolic blood pressure \>= 150 mmHg) by antihypertensive treatment:

usual strategy: reduction of systolic blood pressure to below 140 mmHg, independently of diastolic blood pressure levels;
intensive strategy: reduction of systolic blood pressure to below 130 mmHg, independently of diastolic blood pressure levels. During the initial run in period two qualifying visits at distance of 7-14 days will be carried out to establish whether blood pressure remains uncontrolled (systolic blood pressure \>=150 mmHg)by current drug treatment. At the end of the second visit eligible patients will be admitted to the study and the following examinations will be carried out: clinical visit, routine laboratory tests, 12-lead ECG. At this point eligible patients will be randomised to one of the two blood pressure goals outlined above. Subsequent clinical visits will be carried out at 4 month-intervals up to the end of the study (4, 8, 12, 16, 20, 24 months).

Trial Health

On Track

Trial Health Score

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

Enrollment

1,111

participants targeted

Target at P75+ for phase_4 hypertension

Timeline

Completed

Started Feb 2005

Longer than P75 for phase_4 hypertension

Geographic Reach

1 country

45 active sites

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

3.9 years study duration

Study Start

First participant enrolled

February 1, 2005

Completed

1.9 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2007

Completed

3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2007

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed

Last Updated

February 3, 2021

Status Verified

March 1, 2013

Enrollment Period

3.9 years

First QC Date

January 12, 2007

Last Update Submit

February 2, 2021

Conditions

Hypertension

Keywords

hypertensionsystolic blood pressure

Outcome Measures

Primary Outcomes (1)

changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG).
0, 12, 24 months

Study Arms (2)

Intensive Strategy

OTHER

Drug: Triatec 10 mgDrug: Triatec HCT 5Drug: Lasix 25Drug: Micardis 80 mgDrug: Micardis plus 80/12.5Drug: Catapresan TTS 2Drug: Norvasc 10 mgDrug: Triatec 5 mgDrug: Pluscor

Usual Strategy

OTHER

Drug: Triatec 10 mgDrug: Triatec HCT 5Drug: Lasix 25Drug: Micardis 80 mgDrug: Micardis plus 80/12.5Drug: Catapresan TTS 2Drug: Norvasc 10 mgDrug: Triatec 5 mgDrug: Pluscor

Interventions

Triatec 10 mgDRUG

Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).