Summary
Candesartan Cilexetil has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Hypertension would be drug repurposing rather than first-in-human development. This does not mean it is approved for Hypertension. ClinicalTrials.gov lists 8 registered trials linking Candesartan Cilexetil to Hypertension: 1 is currently recruiting; 5 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00741585). It plans or enrolled 21983 participants. Registration activity spans 2007 to 2024. The literature layer holds 11 publications for this pair: 4 meta-analyses, 1 systematic review, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2005 to 2024. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Essential Hypertension ranks 376 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Not well-characterized as population baseline; routinely framed as irreversible in clinical culture despite contrary trial evidence.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 78.5 (trials 28.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 0 active / not yet recruiting, 5 completed, 2 other |
| Linked publications | 11 (5 clinical trial publications, 4 meta-analyses, 1 systematic review, 1 randomised controlled trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT01682564 | To Evaluate the Efficacy and Safety on Blood Pressure In Patients With Hypertension Diagnosed Congestive Heart Failure 2012 | completed | Phase 4 | 169 |
| NCT00741585 | Prognostic Value of the Circadian Pattern of Ambulatory Blood Pressure for Multiple Risk Assessment 2008 | completed | Phase 4 | 21,983 |
| NCT03231982 | Study to Confirm the Efficacy and Safety of Fixed-dose Combinations of Amlodipine and Candesartan 2017 | status unknown | Phase 4 | 210 |
| NCT01788358 | Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential Hypertension 2013 | completed | Phase 3 | 508 |
| NCT06212648 | Evaluate the Efficacy and Safety of SPC1001 and Monotherapy in Patients With Essential Hypertension 2022 | completed | Phase 2 | 253 |
| NCT06826872 | Efficacy and Safety of SPC1001 in Patients With Essential Hypertension 2024 | recruiting | Phase 2 | 252 |
| NCT02206165 | A Dose Selection Trial of CKD-330 in Patients With Essential Hypertension 2014 | status unknown | Phase 2 | 456 |
| NCT00608153 | Compliance of Patients With Essential Hypertension Treated With Candesartan or Candesartan/Hydrochlorothiazide 2007 | completed | Not applicable | 1,773 |
Published literature
- Clinical trial publication Phase III randomized clinical trial of efficacy and safety of amlodipine and candesartan cilexetil combination for hypertension treatmentSoh MS, Won KH, Kim JJ et al. · Scientific reports · 2024 · PMID 39358448
- Systematic review Efficacy and Safety of Angiotensin Receptor Blockers in Pediatric Patients (Aged 6 to 18) with Hypertension: A Systematic ReviewBassiri S, Bakhtiari E, Ghaffarian N et al. · Iranian journal of kidney diseases · 2023 · PMID 37337795
- Clinical trial publication Efficacy and Tolerability of Combination Therapy Versus Monotherapy with Candesartan and/or Amlodipine for Dose Finding in Essential Hypertension: A Phase II Multicenter, Randomized, Double-blind Clinical TrialSohn IS, Kim CJ, Ahn T et al. · Clinical therapeutics · 2017 · PMID 28734660
- Clinical trial publication Blood pressure-lowering effects of nifedipine/candesartan combinations in high-risk individuals: subgroup analysis of the DISTINCT randomised trialMancia G, Cha G, Gil-Extremera B et al. · Journal of human hypertension · 2017 · PMID 27511476
- Clinical trial publication Fixed-dose combination of nifedipine gastrointestinal therapeutic system and candesartan cilexetil in patients with moderate-to-severe essential hypertension: an open-label, long-term safety and efficacy studyKjeldsen SE, Dzongowski P, Li N et al. · Journal of clinical pharmacy and therapeutics · 2016 · PMID 27670639
- Clinical trial publication Nifedipine GITS/Candesartan Combination Therapy Lowers Blood Pressure Across Different Baseline Systolic and Diastolic Blood Pressure Categories: DISTINCT Study SubanalysesKjeldsen SE, Cha G, Villa G et al. · Journal of clinical pharmacology · 2016 · PMID 26829251
- Randomized controlled trial Nifedipine plus candesartan combination increases blood pressure control regardless of race and improves the side effect profile: DISTINCT randomized trial resultsKjeldsen SE, Sica D, Haller H et al. · Journal of hypertension · 2014 · PMID 25144296
- Meta-analysis [Efficacy of candesartan cilexetil in hypertensive patients with or without diabetes]El Féghali R, Nisse-Durgeat S, Asmar R · Archives des maladies du coeur et des vaisseaux · 2007 · PMID 17928776
- Meta-analysis Updated meta-analytical approach to the efficacy of antihypertensive drugs in reducing blood pressureBaguet JP, Legallicier B, Auquier P et al. · Clinical drug investigation · 2007 · PMID 17914893
- Meta-analysis Effect of candesartan cilexetil on diabetic and non-diabetic hypertensive patients: meta-analysis of five randomized double-blind clinical trialsFéghali RE, Nisse-Durgeat S, Asmar R · Vascular health and risk management · 2007 · PMID 17583187
- Meta-analysis A meta-analytical approach to the efficacy of antihypertensive drugs in reducing blood pressureBaguet JP, Robitail S, Boyer L et al. · American journal of cardiovascular drugs : drugs, devices, and other interventions · 2005 · PMID 15725044
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Candesartan Cilexetil approved for Hypertension?
Candesartan Cilexetil has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Hypertension would be drug repurposing rather than first-in-human development. This does not mean it is approved for Hypertension. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Candesartan Cilexetil in clinical trials for Hypertension?
ClinicalTrials.gov lists 8 registered trials linking Candesartan Cilexetil to Hypertension: 1 is currently recruiting; 5 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00741585). It plans or enrolled 21983 participants. Registration activity spans 2007 to 2024.
What does the evidence show for Candesartan Cilexetil in Hypertension?
Candesartan Cilexetil has both completed registered trials and synthesis-level publications linked to Hypertension. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.