NCT00135551: COPE

The Combination Therapy of Hypertension to Prevent Cardiovascular Events Trial

Completed Phase 4 Last updated 19 February 2012

What this trial tests

Phase 4 trial testing Angiotensin receptor blockers in Cardiovascular Disease in 3,501 participants. Completed in 1 November 2010.

Timeline

1 May 2003

Primary endpoint
1 May 2010

1 November 2010

Quick facts

Lead sponsor	Seiji Umemoto, M.D., Ph.D.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	3,501
Start date	1 May 2003
Primary completion	1 May 2010
Estimated completion	1 November 2010
Sites	1 location across Japan

Drugs / interventions tested

• Angiotensin receptor blockers — full drug profile →
• β-blockers — full drug profile →
• thiazide diuretics — full drug profile →

Conditions studied

• Cardiovascular Disease — all drugs for Cardiovascular Disease →

Sponsor

Seiji Umemoto, M.D., Ph.D. — full company profile →

Who can join

Adults 40 to 85, any sex, with Cardiovascular Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• A composite of fatal and non-fatal cardiovascular events.
  Time frame: first event
• Achievement of target blood pressure (< 140 mmHg/90 mmHg).
  Time frame: time course

Sponsor's own description

A number of major clinical trials have demonstrated the clinical benefits of lowering blood pressure and have indicated that a majority of patients with hypertension will require more than one drug to achieve optimal blood pressure control.

There is little data showing which antihypertensive combination best protects patients from cardiovascular events and which best achieves the target blood pressure with the fewest adverse events.

The COPE trial is planned to investigate, in patients with hypertension, which combination of the antihypertensive drugs, angiotensin receptor blockers, β-blockers or thiazide diuretics in addition to a long-acting calcium antagonist, benidipine hydrochloride, is superior to achieve the targeted blood pressure and prevent cardiovascular events with the fewest adverse drug effects.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of calcium channel blocker-based combinations on intra-individual blood pressure variability: post hoc analysis of the COPE trial.
   Umemoto S, Ogihara T, Matsuzaki M, Rakugi H, et al · · 2016 · cited 21× · PMID 26490089 · DOI 10.1038/hr.2015.104
2. Effects of calcium channel blocker benidipine-based combination therapy on target blood pressure control and cardiovascular outcome: a sub-analysis of the COPE trial.
   Umemoto S, Ogihara T, Matsuzaki M, Rakugi H, et al · · 2017 · cited 7× · PMID 27904156 · DOI 10.1038/hr.2016.158
3. Comparative efficacy of different antihypertensive drug classes for stroke prevention: A network meta-analysis of randomized controlled trials.
   Yu D, Li JX, Cheng Y, Wang HD, et al · · 2025 · cited 2× · PMID 39982885 · DOI 10.1371/journal.pone.0313309