A double blind, randomized, parallel study to assess the effects of aliskiren/amlodipine and amlodipine monotherapy on ankle foot volume (AFV) in patients naïve to trial drugs with mild to moderate hypertensio

Conditions: hypertension
MedDRA version: M15Level: LLTClassification code 10020772Term: <Manually entered code. Term in E.1.1>

Registration Number: EUCTR2009-014359-63-NL

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 88

Inclusion Criteria

1. Male or female 18-65 yrs old (inclusive).
2. Patients with a diagnosis of hypertension and naïve to antihypertensive medication: Mild
to moderate hypertension (msDBP =90 mmHg and <110 mmHg and/or msSBP =140
mmHg and <180 mmHg) at screening, and after 2 weeks of placebo run-in period.
OR
Patients with (a history of) mild to moderate hypertension with a controlled BP at
screening lower than 180/100 mmHg (due to antihypertensive medication), and after 2
weeks of placebo run-in period their msDBP =90 mmHg and <110 mmHg; and/or msSBP
=140 mmHg and <180 mmHg.
3. Amlodipine naïve or no amlodipine use in previous year from screening visit.
4. Female subjects must be of non-child bearing potential as defined as postmenopausal
females with no regular menstrual bleeding for at least one (1) year prior to initial dosing.
Menopause will be confirmed by a plasma FSH level of >40IU/L at screening,
OR
Female subjects surgically sterilized at least 6 months prior to screening (Surgical
sterilization procedures should be supported with clinical documentation made available
to the sponsor and noted in the Relevant Medical History/ Current Medical Conditions
section of the CRF. All female subjects must have negative pregnancy results at screening
and at baseline (regardless of reported reproductive status).
5. Body mass Index (BMI) must be 18-32 kg/m2 (inclusive) and subjects must weigh at least
50 kg at screening and baseline.
6. Able to communicate well with the investigator, and to understand and comply with the
requirements of the study and able to provide written informed consent prior to study
participation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Inability of the subjects to switch from all prior antihypertensive medications safely as required by the protocol and need for drugs other than study drugs at the time of baseline.
2.Severe hypertension (msSBP =180 mmHg and/or msDBP =110 mmHg) at screening and/or baseline.
3.Pregnant or nursing (lactating) women
4.History or evidence of a secondary form of hypertension
5.Any history within 12 months prior to Visit 1 of the following: hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
6.Previous or current diagnosis of heart failure (NYHA Class II-IV)
7.Confirmed serum potassium =5.3 mEq/L (mmol/L) at screening or baseline
8.Patients with Type 1 or Type 2 diabetes mellitus.
9.Current angina pectoris requiring pharmacological therapy
10.Second or third degree heart block without a pacemaker, or potentially life-threatening arrhythmia during the 12 months prior to screening
11.Clinically symptomatic valvular heart disease at screening visit
12.Known or suspected contraindications, including history of allergy or hypersensitivity to renin inhibitors (such as angioedema), calcium channel blockers, or to drugs with similar chemical structures
13.Participation in any clinical investigation within four (4) weeks prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
14.A past medical history of clinically significant ECG abnormalities.
15.History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
16.History or evidence of drug or alcohol abuse within the last 12 months.
17.Any subjects clinical management which necessities use of diuretic and cannot be discontinued before the start of trial.
18.Any surgical or medical condition which in the opinion of the investigator may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
19.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. The Investigator should make this determination in consideration of the subject’s medical history and/or clinical or laboratory evidence of any of the following:
•History of inflammatory bowel diseases, ulcers, gastrointestinal or rectal bleeding; during the last 12 months
•History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
•Currently active gastritis, duodenal or gastric ulcers, or history of gastrointestinal bleeding during the 3 months prior to screening visit.
•Liver disease or liver injury as indicated by abnormal liver function tests such as SGOT (AST), SGPT (ALT), ?-GGT, alkaline phosphatase, or serum bilirubin. The Investigator should be guided by the following criteria:
oAny single parameter may not exceed 3 x upper limit of normal (ULN). A single parameter elevated up to and including 3 x ULN should be re-checked once more as soon as possible, and in all cases, at least prior to enrollment/rando

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •To assess and compare the effects of aliskiren/amlodipine and amlodipine on pedal edema after 4 weeks treated as measured by ankle foot volume (AFV) (water displacement method) in patients with mild to moderate hypertension;Secondary Objective: •To assess the safety and tolerability of aliskiren/ amlodipine and amlodipine in patients with mild to moderate hypertension<br><br>Exploratory objective<br>•To investigate the effect on ms SBP and ms DBP of SPA100 and amlodipine in subjects with mild to moderate hypertension.<br>;Primary end point(s): Assessment on the effects of aliskiren/amlodipine and amlodipine on pedal edema measured by ankle foot volume (AFV) in patients naive to trial drugs with mild to moderate hypertension

Secondary Outcome Measures

Name	Time	Method

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