Monotherapy vs Dual Therapy for Initial Treatment for hypertension - Monotherapy vs Dual Therapy for Initial Treatment for hypertensio

• Conditions: Resistant Hypertension; MedDRA version: 14.1Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2008-007749-29-GB
• Lead Sponsor: R&D Department,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-29
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Aged 18-79
2.Male subjects or female subjects taking adequate contraception such as the oral contraceptive pill, an intra uterine device or who are surgically sterilised or postmenopausal Females.
3. Either systolic BP >=150 mmHg or diastolic BP >=95mmHg. Pts may be included if the PI anticipates BP criteria for inclusion will be met at randomisation.
4.Either never-treated or received a maximum of one antihypertensive drug.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. SBP > 200 mmHg or DBP > 120 mmHg
2.Secondary or accelerated phase hypertension;
3.eGFR < 45 mls/min;
4.Contra-indication or previous intolerance to any trial therapy
5.Failure to record required home BP readings during placebo run-in.
6.Significant co-morbidity (investigator opinion but to include alcoholism,
terminal illness, documented non-attendance at clinics etc.
• Diabetes Type 1
•Plasma K+ outside normal range on two successive measurements during screening
• Requirement for treatment with =2 drugs (which can be a CCB and/or {ACEi OR ARB OR direct renin inhibitor OR ß-blocker}) in order to reduce blood pressure to =180/120 mmHg
•Requirement for diuretic therapy
• Requirement for ACE inhibitor (or ARB) therapy (other than for hypertension)
•Absolute contra-indications to any of the study drugs (listed on their data-sheet)
•Current therapy for cancer
•Anticipation of change in medical status during course of trial (e.g. surgical intervention > 2 weeks convelescence, actual or planned pregnancy)
•Inability to give informed consent
•Not on stable doses of all concomitant medications for a minimum of 4 weeks prior to randomisation
•Participation in a clinical study involving an investigational drug or device within 4 weeks of screening.
•Any concomitant condition that, in the opinion of the investigator, may adversely affect the safety and/or efficacy of the study drug or severely limit the subject’s lifespan or ability to complete the study (eg, alcohol or drug abuse, disabling or terminal illness, mental disorders).
•Treatment with any of the following prohibited medications:
a.Oral corticosteroids within 3 months of Screening. Treatment with corticosteroids is also prohibited during study participation.
b.Acetylsalicylic acid in excess of 325 mg per day.
c.Chronic stable or unstable use of non-steroidal anti-inflammatory drugs (NSAIDs) other than acetylsalicylic acid is prohibited. Chronic use is defined as >3 consecutive or nonconsecutive days of treatment per week. In addition, the intermittent use of NSAIDs is strongly discouraged throughout the duration of this study. If intermittent treatment is required, NSAIDs must not be used for more than a total of 2 days. For all subjects requiring analgesic or anti-pyretic agents, the use of paracetamol is recommended during study participation.
d.The use of short-acting oral nitrates (eg, sublingual nitroglycerin) is permitted; however, subjects should not take short-acting oral nitrates within 4 hours of Screening or any subsequent study visit.
e.The use of long-acting oral nitrates (eg, Isordil) is permitted; however, the dose must be stable for at least 2 weeks prior to Screening and Randomisation.
f.The use of sympathomimetic decongestants or ß-agonists is permitted; however, not within 1 week prior to Screening or Randomisation. In addition, use of these medications will be prohibited within 1 day prior to any clinic visit.
g.The use of theophylline is permitted; however, the dose must be stable for at least 4 weeks prior to Screening and throughout study participation.
h.The use of phosphodiesterase (PDE) type V inhibitors is permitted; however, subjects must refrain from taking these medications within 1 day of Screening or any subsequent study visit.
i. The use of alpha-blockers is not permitted – with the exception of afluzosin and tamsulosin for prostatic symptoms

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified