The primary objective of this study is to demonstrate the efficacy of the combination therapy of aliskiren (150 mg and 300 mg) and HCTZ 25 mg in hypertensive patients who do not show sufficient blood pressure response to a 4-week treatment of HCTZ…
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
MSDBP (mean sitting diastolic bloodpressure)
Secondary outcome
MSDBP (mean sitting systolic bloodpressure)
ECG, Adeverse Events, labevaluations, physical examination
proportion of patients achieving a blood pressure control target of < 140/90
mmHg at the end of study for all treatments arms
Background summary
The renin-angiotensin system (RAS) plays a major role in the regulation of
arterial blood pressure and the pathogenesis of hypertension. Aliskiren is a
new drug from a new class of antihypertensiva, the renin inhibitors. This renin
inhibitor blocks the RAS so that angiotensinogen is no longer converted in
angiotensin I.
Thiazide-type diuretics have been recommended as first line antihypertensive
therapy. HCTZ is the most commonly prescribed thiazide-type diuretic. Adequate
and timely control of blood pressure in hypertensive patients is the goal for
the treatment of hypertension. In order to achieve this goal two or more
antihypertensive drugs may be needed. The combination of a RAS blocking drug
such as ACE inhibitor or ARB and a diuretic such as HCTZ is commonly used in
the clinical practice for the treatment of hypertension. This Phase III study
is designed to evaluate the efficacy and the safety of the combination of
aliskiren/HCTZ (150/25 mg) and aliskiren/HCTZ (300/25 mg) in patients with
essential hypertension whose blood pressure is not adequately controlled by
HCTZ 25 mg monotherapy.
Study objective
The primary objective of this study is to demonstrate the efficacy of the
combination therapy of aliskiren (150 mg and 300 mg) and HCTZ 25 mg in
hypertensive patients who do not show sufficient blood pressure response to a
4-week treatment of HCTZ 25 mg.
Study design
This is a randomized, double-blind, parallel-group, multi center, phase III
study. For every patient the study starts with a screeningsvisit and for
patients currently on antihypertensiva a washout period is started on this
visit for a maximum of 10 days. All patients will be treated with HCTZ 25 mg
during 4 weeks in the single-blind run-in period. If after this period the
patient is not adequately controlled by HCTZ monotherapy, this means on visit 5
a MSDBP * 90 mmHg en < 110 mmHg, and additionally fulfills all other
in/exclusion criteria, then patient is randomized in the following 3 arms:
aliskiren/HCTZ (150/25 mg) or aliskiren/HCTZ (300/25 mg) or HCTZ 25 mg
monotherapy. This double-blind treatment will last 8 weeks.
Intervention
Patients are treated with HCTZ 25 mg from visit 2 during 4 weeks and on visit 5
patients recieve: HCTZ (25 mg), or aliskiren/HCTZ 150/25 mg or aliskiren/HCTZ
300/25 mg (ratio 1:1:1) during 8 weeks.
Study burden and risks
Burden:
9 visits of approximately 1 hour during 12-13 weeks, 4x blooddraw.
Risks:
From earlier studies it appeared that the adverse events seen with aliskiren
are comparable with placebo.
The most common adverse events reported in research studies to date with
aliskiren were:
* Headache
* Diarrhea
* Dizziness
* Fatigue
* Back pain
* Nausea
* Nasopharyngitis
The most common side effects to date with HCTZ are electrolyte (blood salt) and
fluid imbalance (symptoms: dry mouth, fatique and muscle cramps), increase in
blood glucose level, and general weakness.
Clinical studies testing the combination of aliskiren + HCTZ have also been
done and some are ongoing. In clinical studies, this combination of
aliskiren/HCTZ was well tolerated. The most common adverse events reported to
date were headache, diarrhea, nasopharyngitis (inflammation of the nose and
pharynx), and dizziness.
raapopseweg 1
6824 DP
Nederland
raapopseweg 1
6824 DP
Nederland
Listed location countries
Age
Inclusion criteria
For full list, see protocol;Patients with a diagnosis of hypertension:;Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP * 95 mmHg and < 110 mmHg at Visit 1.;All patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP * 85 mmHg and < 110 mmHg at Visit 2.;All patients must have a msDBP * 90 mmHg and < 110 mmHg at Visit 5.
Exclusion criteria
For full list, see protocol;Severe hypertension (msDBP * 110 mmHg and/or msSBP * 180 mmHg).;History or evidence of a secondary form of hypertension.;Previous or current diagnosis of heart failure.;History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).;Serum potassium < 3.5 mEq/L (mmol/L) or * 5.3 mEq/L (mmol/L), serum sodium less than the lower limit of normal or dehydration.;Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled based on the investigator*s clinical judgment. Patients with diabetes mellitus enrolled in this study should be well controlled. It is recommended that patients currently being treated for diabetes mellitus be on a stable dose of oral antidiabetic medication for at least 4 weeks prior to Visit 1.;Patients who previously enrolled in the active drug treatment period of a clinical trial that contained the treatment combination of aliskiren/HCTZ.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2005-004580-40-NL |
| Other | NA |
| CCMO | NL13582.003.06 |