Phase 3 Completed N=837 Randomized Double-blind Treatment

Perindopril Amlodipine for the Treatment of Hypertension

Hypertension

Source: ClinicalTrials.gov NCT01556997 ↗

Enrolled (actual)

837

Serious AEs

0.7%

Results posted

Aug 2015

Primary outcomePrimary: Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP). — -15.7; -13.2; -9.5 mmHg — p=0.025

Summary

The purpose of the study is to evaluate the safety and efficacy of a fixed-dose combination drug compared to two other drugs (monotherapies) in controlling hypertension.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).	-15.7; -13.2; -9.5	0.025 sig
SECONDARY Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).	-23.4; -19.6; -13.4	0.025 sig

Eligibility Criteria

Inclusion Criteria

Essential hypertension
For female subjects, a negative serum pregnancy test
Ability to provide written informed consent

Exclusion Criteria

Night shift workers whose work hours include midnight to 4:00 a.m.
Secondary hypertension
An arm size that precludes the use of the digital blood pressure monitor cuff (arm size > 42 cm)
Renal dysfunction, severe renal impairment, bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, subjects with only 1 kidney, or post-renal transplant subjects
Female subjects who are pregnant, planning to become pregnant
History of malignancy within 5 years
Primary aldosteronism
Heart failure (NYHA functional class 3-4), hypertrophic obstructive cardiomyopathy, or hemodynamically relevant stenosis of the aortic or mitral valve
Significant cardiac arrhythmias, MI, stroke, CABG, PTCA, unstable angina
Known hypersensitivity to any component of the study drugs

Other protocol-defined inclusion/exclusion criteria may apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01556997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.