Phase 4
Completed N=183
Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) Trial
Blood Pressure
Source: ClinicalTrials.gov NCT01030458 ↗
Enrolled (actual)
183
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcomePrimary: Sitting Systolic Blood Pressure on Automated Measurement — 127.2; 134.1 mmHg
Summary
The purpose of this study is to compare the blood pressure lowering efficacy of a treatment regimen based on a dihydropyridine calcium-channel blocker combined with an angiotensin II type-1 receptor blocker with the recommended treatment regimen based on a low-dose thiazide diuretic combined with a beta-blocker.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sitting Systolic Blood Pressure on Automated Measurement |
127.2; 134.1 | — |
| SECONDARY Time to Blood Pressure Control |
12; 18 | — |
| SECONDARY Side-effects to Study Medications |
1; 1 | — |
| SECONDARY Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up |
58; 40 | — |
Eligibility Criteria
Inclusion Criteria
- Women or men within an age range from 30 to 69 years with uncomplicated hypertension.
- Blood pressure measured in the sitting position after at least 5 minutes rest (average of three readings at the last run-in-visit) should range from 140 to 179 mm Hg systolic or from 90 to 109 mm Hg diastolic (grades 1 or 2 of hypertension). Patients must have uncomplicated hypertension with a maximum of two additional risk factors, as defined in the 2007 guidelines of the European Societies of Hypertension and Cardiology.
- Systolic blood pressure in the upright position must be at least 110 mm Hg (mean of three readings obtained immediately after the patient has assumed a standing position).
- Patients who have never been treated for hypertension or in whom previous antihypertensive drug treatment has been discontinued for at least four weeks before the last run-in visit can be randomised. If two weeks after discontinuation of previous antihypertensive treatment the blood pressure is higher than 160 mm Hg systolic or higher than 100 mm Hg diastolic and if the patient has complaints, the patient can be randomised immediately to active blood pressure lowering treatment with either the newer or older antihypertensive drugs.
- The patient must provide informed written consent.
Exclusion Criteria
- Premenopausal women not applying anticonception.
- A history of cardiovascular disease.
- Secondary hypertension.
- Electrocardiographic left ventricular hypertrophy.
- More than two cardiovascular risk factors in addition to hypertension.
- Diabetes mellitus.
- Renal dysfunction.
- Recent treatment with two or more antihypertensive drugs or a contra-indication to discontinue blood pressure lowering agents for 4 weeks.
- Severe non-cardiovascular disease.
- Known contra indications for the first-line study medications.
Data sourced from ClinicalTrials.gov (NCT01030458). 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.