High-Dose Quinapril Versus Low-Dose Quinapril Plus Amlodipine in the Treatment of High-Risk Hypertensive Patients

Impact of High-Dose Quinapril Versus Low-Dose Quinapril Plus Amlodipine on Autonomic Regulation and on Sympathetic Activation in Response to Cold Exposure in Hypertensive Patients With Impaired Glucose Tolerance, Diabetes or Coronary Artery Disease

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00313547

Enrollment

Registered

2006-04-12

Start date

2006-04-30

Completion date

2008-03-31

Last updated

2008-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Blood pressure, Hypertension, Renin, Aldosterone, Heart rate variability

Brief summary

The purpose of this study is to compare the impact of two blood pressure lowering treatments (high dose quinapril versus low dose quinapril plus amlodipine) on variations in heart rate over 24 hours.

Interventions

DRUGQuinapril 40 mg

DRUGQuinapril 10 mg and amlodipine 5 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with a documented history of hypertension defined as: SBP \> or = 140 mmHg or DBP \> or = 90 mmHg if hypertension untreated or patients currently treated for hypertension. * Documented CAD or diabetes or impaired glucose tolerance * Sinus rhythm Principal

Exclusion criteria

* Previous intolerance or allergic reaction to an ACE inhibitor, an ARB or dihydropyridine calcium channel blocker * History of angioedema or cough related to previous ACE inhibitor use. * Systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg in untreated patients * Systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg in patients currently treated by an ACE inhibitor or an ARB * Creatinine clearance \< 30 ml/min * Significant liver dysfunction * Current serum potassium \> or = 5 mmol/L or a history of marked ACE inhibitor or ARB induced hyperkalemia resulting in either a serum potassium \> or = 5.5 mmol/L or a life-threatening adverse event. * History of HF or known LVEF \< or = 45% * Bilateral renal artery stenosis (or unilateral if only one kidney) * Unstable angina, myocardial infarction or coronary revascularization within the last 3 months. * Connective tissue disease or chronic inflammatory condition * Active malignancy * Active infection in the last 2 weeks * Inability or any contraindication to perform an exercise test.

Design outcomes

Primary

Measure	Time frame
Heart rate variability	—

Secondary

Measure	Time frame
Renin, aldosterone	—
MMPs	—
Oxidative stress	—
Norepinephrine	—
Tolerability	—
Exercise tolerance at 20 and -8 degree celsius	—
Blood pressure	—
Impact of selected pharmacogenetic polymorphisms	—
Lactate	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026